Frequencies for enfrep20140115 dataset : by Jean Roth , jroth@nber.org , 18 Dec 2015 Frequencies for producttype variable in enfrep20140115 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Devices | 92 82.88 82.88 Drugs | 9 8.11 90.99 Food | 10 9.01 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for eventid variable in enfrep20140115 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 64727 | 3 2.70 2.70 65373 | 1 0.90 3.60 65409 | 2 1.80 5.41 66064 | 1 0.90 6.31 66273 | 1 0.90 7.21 66323 | 4 3.60 10.81 66398 | 1 0.90 11.71 66501 | 2 1.80 13.51 66568 | 5 4.50 18.02 66603 | 1 0.90 18.92 66622 | 1 0.90 19.82 66744 | 1 0.90 20.72 66833 | 1 0.90 21.62 66870 | 1 0.90 22.52 66915 | 1 0.90 23.42 66919 | 1 0.90 24.32 66943 | 1 0.90 25.23 67005 | 7 6.31 31.53 67025 | 2 1.80 33.33 67034 | 5 4.50 37.84 67037 | 1 0.90 38.74 67039 | 1 0.90 39.64 67040 | 1 0.90 40.54 67049 | 2 1.80 42.34 67050 | 1 0.90 43.24 67087 | 1 0.90 44.14 67093 | 1 0.90 45.05 67108 | 1 0.90 45.95 67112 | 1 0.90 46.85 67124 | 1 0.90 47.75 67131 | 2 1.80 49.55 67132 | 1 0.90 50.45 67134 | 1 0.90 51.35 67148 | 1 0.90 52.25 67150 | 1 0.90 53.15 67161 | 1 0.90 54.05 67166 | 50 45.05 99.10 67200 | 1 0.90 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for status variable in enfrep20140115 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Completed | 5 4.50 4.50 Ongoing | 104 93.69 98.20 Terminated | 2 1.80 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for recallingfirm variable in enfrep20140115 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- ANAT, LLC | 2 1.80 1.80 Aesculap, Inc. | 1 0.90 2.70 Alere San Diego, Inc. | 1 0.90 3.60 Ansell Sandel Medical Industries LLC | 7 6.31 9.91 ArthroCare Medical Corporation | 1 0.90 10.81 Baugher Ranch Organics, Inc | 1 0.90 11.71 Carestream Health Inc. | 1 0.90 12.61 Compounding Centre At Blue Ridge | 5 4.50 17.12 Covidien | 1 0.90 18.02 Creole & Company, LLC | 1 0.90 18.92 Del Monaco Specialty Foods Inc. | 1 0.90 19.82 EOS Imaging | 1 0.90 20.72 Fresenius Medical Care Holdings, Inc. | 1 0.90 21.62 GE Healthcare, LLC | 1 0.90 22.52 HP Hood LLC | 1 0.90 23.42 ICU Medical, Inc. | 50 45.05 68.47 Innovative Labs, LLC | 2 1.80 70.27 Integra LifeSciences Corp. | 2 1.80 72.07 Invacare Corporation | 1 0.90 72.97 Materialise USA LLC | 1 0.90 73.87 Midmark Corp dba Progeny Inc | 1 0.90 74.77 Mutual Pharmaceutical Company, Inc. | 3 2.70 77.48 Nova Biomedical Corporation | 1 0.90 78.38 On Site Gas Systems Inc. | 1 0.90 79.28 Optimedica Corporation | 1 0.90 80.18 Perrigo of SC | 1 0.90 81.08 RTI Surgical, Inc. | 1 0.90 81.98 Safeway Inc | 1 0.90 82.88 Siemens Healthcare Diagnostics, Inc. | 2 1.80 84.68 Smiths Medical ASD, Inc. | 5 4.50 89.19 SpineFrontier, Inc. | 1 0.90 90.09 Stryker Instruments Div. of Stryker C.. | 1 0.90 90.99 The Anspach Effort, Inc. | 7 6.31 97.30 Trans American Medical, Inc. | 1 0.90 98.20 Watson Laboratories Inc | 1 0.90 99.10 Welch Allyn Protocol, Inc | 1 0.90 100.00 ----------------------------------------+----------------------------------- Total | 111 100.00 Frequencies for city variable in enfrep20140115 dataset : City | Freq. Percent Cum. -------------------+----------------------------------- Austin | 1 0.90 0.90 Beaverton | 1 0.90 1.80 Beverly | 1 0.90 2.70 Bloomfield | 2 1.80 4.50 Boulder | 1 0.90 5.41 Center Valley | 1 0.90 6.31 Chatsworth | 7 6.31 12.61 Corona | 1 0.90 13.51 Elyria | 1 0.90 14.41 Greenville | 1 0.90 15.32 Hauppauge | 2 1.80 17.12 Keene | 5 4.50 21.62 Lincolnshire | 1 0.90 22.52 Lindon | 1 0.90 23.42 Lynnfield | 1 0.90 24.32 Marquette | 1 0.90 25.23 Morgan Hill | 1 0.90 26.13 Newark | 2 1.80 27.93 Newington | 1 0.90 28.83 Orland | 1 0.90 29.73 Palm Beach Gardens | 7 6.31 36.04 Paris France | 1 0.90 36.94 Philadelphia | 3 2.70 39.64 Plainsboro | 2 1.80 41.44 Pleasanton | 1 0.90 42.34 Plymouth | 1 0.90 43.24 Portage | 1 0.90 44.14 Raleigh | 5 4.50 48.65 Rochester | 1 0.90 49.55 San Clemente | 50 45.05 94.59 San Diego | 1 0.90 95.50 Sunnyvale | 1 0.90 96.40 Waltham | 2 1.80 98.20 Waukesha | 1 0.90 99.10 new orleans | 1 0.90 100.00 -------------------+----------------------------------- Total | 111 100.00 Frequencies for state variable in enfrep20140115 dataset : State | Freq. Percent Cum. ------------+----------------------------------- | 1 0.90 0.90 CA | 63 56.76 57.66 CO | 1 0.90 58.56 CT | 3 2.70 61.26 DE | 2 1.80 63.06 FL | 7 6.31 69.37 IL | 1 0.90 70.27 LA | 1 0.90 71.17 MA | 4 3.60 74.77 MI | 3 2.70 77.48 NC | 5 4.50 81.98 NH | 5 4.50 86.49 NJ | 2 1.80 88.29 NY | 3 2.70 90.99 OH | 1 0.90 91.89 OR | 1 0.90 92.79 PA | 4 3.60 96.40 SC | 1 0.90 97.30 TX | 1 0.90 98.20 UT | 1 0.90 99.10 WI | 1 0.90 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for country variable in enfrep20140115 dataset : Country | Freq. Percent Cum. ------------+----------------------------------- FR | 1 0.90 0.90 US | 110 99.10 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for voluntarymandated variable in enfrep20140115 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- Voluntary: Firm Initiated | 111 100.00 100.00 --------------------------+----------------------------------- Total | 111 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20140115 dataset : Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 1 0.90 0.90 E-Mail | 5 4.50 5.41 Letter | 90 81.08 86.49 Other | 2 1.80 88.29 Telephone | 10 9.01 97.30 Two or more of the following: Email, .. | 2 1.80 99.10 Visit | 1 0.90 100.00 ----------------------------------------+----------------------------------- Total | 111 100.00 Frequencies for distributionpattern variable in enfrep20140115 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- CA | 3 2.70 2.70 CT | 2 1.80 4.50 En-route to one location in Sarasota,.. | 1 0.90 5.41 FL, IL, MI, MN, OR, PA & TX | 1 0.90 6.31 LA | 1 0.90 7.21 NC | 5 4.50 11.71 Nationwide | 2 1.80 13.51 Nationwide Distribution | 1 0.90 14.41 Nationwide Distribution - USA includi.. | 1 0.90 15.32 Nationwide Distribution. | 1 0.90 16.22 Nationwide and Puerto Rico. | 3 2.70 18.92 Pennsylvania & New York | 1 0.90 19.82 Southern CA | 1 0.90 20.72 US Distribution: MO only. | 1 0.90 21.62 US Distribution: Maryland only. | 2 1.80 23.42 US Distribution: Michigan only. | 1 0.90 24.32 US Distribution: PA only. | 1 0.90 25.23 US Distribution: including states of:.. | 1 0.90 26.13 US Distribution: including states of:.. | 1 0.90 27.03 US Distribution: including states of:.. | 1 0.90 27.93 US Distribution: including states of:.. | 1 0.90 28.83 Worldwide Distribution - USA (nationw.. | 1 0.90 29.73 Worldwide Distribution - USA (nationw.. | 1 0.90 30.63 Worldwide Distribution - USA (nationw.. | 1 0.90 31.53 Worldwide Distribution - USA (nationw.. | 1 0.90 32.43 Worldwide Distribution - USA (nationw.. | 2 1.80 34.23 Worldwide Distribution - USA includin.. | 2 1.80 36.04 Worldwide Distribution - USA includin.. | 1 0.90 36.94 Worldwide Distribution - USA includin.. | 50 45.05 81.98 Worldwide Distribution-USA (nationwid.. | 1 0.90 82.88 Worldwide Distribution: US (nationwid.. | 4 3.60 86.49 Worldwide Distribution: US (nationwid.. | 7 6.31 92.79 Worldwide Distribution: US (nationwid.. | 1 0.90 93.69 Worldwide Distribution: US (nationwid.. | 5 4.50 98.20 Worldwide Distribution: US (nationwid.. | 1 0.90 99.10 Worldwide distribution: US (nationwid.. | 1 0.90 100.00 ----------------------------------------+----------------------------------- Total | 111 100.00 Frequencies for recallnumber variable in enfrep20140115 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- D-397-2014 | 1 0.90 0.90 D-398-2014 | 1 0.90 1.80 D-399-2014 | 1 0.90 2.70 D-400-2014 | 1 0.90 3.60 D-401-2014 | 1 0.90 4.50 D-402-2014 | 1 0.90 5.41 D-403-2014 | 1 0.90 6.31 D-404-2014 | 1 0.90 7.21 D-405-2014 | 1 0.90 8.11 F-1377-2014 | 1 0.90 9.01 F-1378-2014 | 1 0.90 9.91 F-1379-2014 | 1 0.90 10.81 F-1380-2014 | 1 0.90 11.71 F-1381-2014 | 1 0.90 12.61 F-1382-2014 | 1 0.90 13.51 F-1383-2014 | 1 0.90 14.41 F-1384-2014 | 1 0.90 15.32 F-1385-2014 | 1 0.90 16.22 F-1645-2013 | 1 0.90 17.12 Z-0491-2014 | 1 0.90 18.02 Z-0529-2014 | 1 0.90 18.92 Z-0532-2014 | 1 0.90 19.82 Z-0611-2014 | 1 0.90 20.72 Z-0621-2014 | 1 0.90 21.62 Z-0622-2014 | 1 0.90 22.52 Z-0623-2014 | 1 0.90 23.42 Z-0624-2014 | 1 0.90 24.32 Z-0625-2014 | 1 0.90 25.23 Z-0626-2014 | 1 0.90 26.13 Z-0627-2014 | 1 0.90 27.03 Z-0628-2014 | 1 0.90 27.93 Z-0629-2014 | 1 0.90 28.83 Z-0630-2014 | 1 0.90 29.73 Z-0631-2014 | 1 0.90 30.63 Z-0632-2014 | 1 0.90 31.53 Z-0633-2014 | 1 0.90 32.43 Z-0634-2014 | 1 0.90 33.33 Z-0635-2014 | 1 0.90 34.23 Z-0636-2014 | 1 0.90 35.14 Z-0637-2014 | 1 0.90 36.04 Z-0638-2014 | 1 0.90 36.94 Z-0639-2014 | 1 0.90 37.84 Z-0640-2014 | 1 0.90 38.74 Z-0641-2014 | 1 0.90 39.64 Z-0642-2014 | 1 0.90 40.54 Z-0643-2014 | 1 0.90 41.44 Z-0644-2014 | 1 0.90 42.34 Z-0645-2014 | 1 0.90 43.24 Z-0646-2014 | 1 0.90 44.14 Z-0647-2014 | 1 0.90 45.05 Z-0648-2014 | 1 0.90 45.95 Z-0649-2014 | 1 0.90 46.85 Z-0650-2014 | 1 0.90 47.75 Z-0651-2014 | 1 0.90 48.65 Z-0652-2014 | 1 0.90 49.55 Z-0653-2014 | 1 0.90 50.45 Z-0654-2014 | 1 0.90 51.35 Z-0655-2014 | 1 0.90 52.25 Z-0656-2014 | 1 0.90 53.15 Z-0657-2014 | 1 0.90 54.05 Z-0658-2014 | 1 0.90 54.95 Z-0659-2014 | 1 0.90 55.86 Z-0660-2014 | 1 0.90 56.76 Z-0661-2014 | 1 0.90 57.66 Z-0662-2014 | 1 0.90 58.56 Z-0663-2014 | 1 0.90 59.46 Z-0664-2014 | 1 0.90 60.36 Z-0665-2014 | 1 0.90 61.26 Z-0666-2014 | 1 0.90 62.16 Z-0667-2014 | 1 0.90 63.06 Z-0668-2014 | 1 0.90 63.96 Z-0669-2014 | 1 0.90 64.86 Z-0670-2014 | 1 0.90 65.77 Z-0671-2014 | 1 0.90 66.67 Z-0672-2014 | 1 0.90 67.57 Z-0673-2014 | 1 0.90 68.47 Z-0674-2014 | 1 0.90 69.37 Z-0675-2014 | 1 0.90 70.27 Z-0676-2014 | 1 0.90 71.17 Z-0677-2014 | 1 0.90 72.07 Z-0678-2014 | 1 0.90 72.97 Z-0679-2014 | 1 0.90 73.87 Z-0680-2014 | 1 0.90 74.77 Z-0681-2014 | 1 0.90 75.68 Z-0682-2014 | 1 0.90 76.58 Z-0683-2014 | 1 0.90 77.48 Z-0684-2014 | 1 0.90 78.38 Z-0685-2014 | 1 0.90 79.28 Z-0686-2014 | 1 0.90 80.18 Z-0687-2014 | 1 0.90 81.08 Z-0688-2014 | 1 0.90 81.98 Z-0689-2014 | 1 0.90 82.88 Z-0690-2014 | 1 0.90 83.78 Z-0691-2014 | 1 0.90 84.68 Z-0692-2014 | 1 0.90 85.59 Z-0693-2014 | 1 0.90 86.49 Z-0694-2014 | 1 0.90 87.39 Z-0695-2014 | 1 0.90 88.29 Z-0696-2014 | 1 0.90 89.19 Z-0697-2014 | 1 0.90 90.09 Z-0698-2014 | 1 0.90 90.99 Z-0699-2014 | 1 0.90 91.89 Z-0700-2014 | 1 0.90 92.79 Z-0701-2014 | 1 0.90 93.69 Z-0702-2014 | 1 0.90 94.59 Z-0703-2014 | 1 0.90 95.50 Z-0704-2014 | 1 0.90 96.40 Z-0705-2014 | 1 0.90 97.30 Z-0706-2014 | 1 0.90 98.20 Z-0707-2014 | 1 0.90 99.10 Z-0708-2014 | 1 0.90 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for classification variable in enfrep20140115 dataset : Classificat | ion | Freq. Percent Cum. ------------+----------------------------------- Class I | 2 1.80 1.80 Class II | 105 94.59 96.40 Class III | 4 3.60 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for productdescription variable in enfrep20140115 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- ***REF BLACKMAX-N***Swivel/Angle Moto.. | 1 0.90 0.90 ***REF IMRI-MOTOR***iMRI Handpiece. U.. | 1 0.90 1.80 ***REF MICROMAX***microMax Handpiece*.. | 1 0.90 2.70 ***REF XMAX***XMax Handpiece***Rx Onl.. | 1 0.90 3.60 10'' (25 cm) Appx 0.38 ml, Smallbore .. | 1 0.90 4.50 10'' (25 cm) Appx 0.41 ml, Smallbore .. | 1 0.90 5.41 10'' (25 cm) Appx 2.9 ml, Trifuse Ext.. | 1 0.90 6.31 10'' Smallbore Pentafuse Ext Set w/5 .. | 1 0.90 7.21 103'' (262 cm) Appx 3.9 ml, Smallbore.. | 1 0.90 8.11 106'' (269 cm) Appx 7.8 ml, Transfer .. | 1 0.90 9.01 11'' Smallbore Bifuse Ext Set w/1.2 M.. | 1 0.90 9.91 11'' Smallbore Bifuse Ext Set w/1.2 M.. | 1 0.90 10.81 120'' 10 Drop Primary Set w/2 BCV-CLA.. | 1 0.90 11.71 13'' Pentafuse Smallbore Ext Set w/Na.. | 1 0.90 12.61 13'' Smallbore Ext Set w/4 Gang 4-Way.. | 1 0.90 13.51 14'' (36 cm ) Appx 0.50 ml, Smallbore.. | 1 0.90 14.41 17 cm (7'') Ext Set w/NanoClave, 2 Ga.. | 1 0.90 15.32 17 cm (7'') Smallbore Trifuse Ext Set.. | 1 0.90 16.22 183 cm (72'') Smallbore Quadfuse Ext .. | 1 0.90 17.12 184 cm (72'') Smallbore Bifuse Ext Se.. | 1 0.90 18.02 28'' (71 cm) Appx 1.0 ml, Smallbore E.. | 1 0.90 18.92 30'' (76 cm) Appx 3.7 ml, Ext Set w/R.. | 1 0.90 19.82 31 cm (12'') Smallbore Bifuse Ext Set.. | 1 0.90 20.72 5'' (13 cm) Appx 0.23 ml, Smallbore E.. | 1 0.90 21.62 5'' Smallbore Ext Set w/MicroClave T-.. | 1 0.90 22.52 5'' Smallbore Ext Set w/MicroClave T-.. | 1 0.90 23.42 5'' Smallbore Ext Set w/MicroClave T-.. | 1 0.90 24.32 6'' (15 cm) Appx 0.24 ml, Smallbore E.. | 1 0.90 25.23 6'' (15 cm) Appx 0.26 ml, Smallbore E.. | 1 0.90 26.13 6'' (15 cm) Appx 0.26 ml, Smallbore E.. | 1 0.90 27.03 6'' (15 cm) Appx 0.27 ml, Smallbore E.. | 1 0.90 27.93 6'' (15 cm) Appx 0.27 ml, Smallbore E.. | 1 0.90 28.83 6'' (15 cm) Appx 0.37 ml, Smallbore B.. | 1 0.90 29.73 6'' (15 cm) Appx 0.56 ml, Smallbore T.. | 1 0.90 30.63 6'' (15 cm) Appx 0.58 ml, Smallbore T.. | 1 0.90 31.53 6.5'' (16.5 cm) Appx 0.30 ml, Smallbo.. | 1 0.90 32.43 7'' (18 cm) Appx 0.24 ml, Smallbore E.. | 1 0.90 33.33 7'' (18 cm) Appx 0.26 ml, Smallbore E.. | 1 0.90 34.23 7'' (18 cm) Appx 0.29 ml, Smallbore E.. | 1 0.90 35.14 7'' (18 cm) Appx 0.29 ml, Smallbore E.. | 1 0.90 36.04 7'' (18 cm) Appx 0.31 ml, Smallbore E.. | 1 0.90 36.94 7'' (18 cm) Appx 0.31 ml, Smallbore E.. | 1 0.90 37.84 7'' (18 cm) Appx 0.33 ml, Smallbore E.. | 1 0.90 38.74 7'' (18cm) Appx 0.32 ml, Smallbore Ex.. | 1 0.90 39.64 78'' Ext Set w/2 BCV-Clave, Remv 2-Ga.. | 1 0.90 40.54 78'' Ext Set w/Check Valve, CLAVE Cle.. | 1 0.90 41.44 8'' (20 cm) Appx 0.43 ml, Smallbore B.. | 1 0.90 42.34 8'' (20 cm) Appx 0.49 ml, Smallbore B.. | 1 0.90 43.24 8'' (20 cm) Appx 0.51 ml, Smallbore E.. | 1 0.90 44.14 8'' Ext Set w/NanoClave'' Stopcock, C.. | 1 0.90 45.05 8'' Smallbore Pentafuse Ext Set w/5 N.. | 1 0.90 45.95 87'' (221 cm) Appx 2.9 ml, Smallbore .. | 1 0.90 46.85 Aesculap Hi-Line XXS handpiece Hi-L.. | 1 0.90 47.75 Anspach B-Blue-S 11.25 cm attachment .. | 1 0.90 48.65 Anspach BLACKMAX-N (Pneumatic motor) .. | 1 0.90 49.55 Armanino Alfredo Sauce; Frozen in 10 .. | 1 0.90 50.45 Arthrocare SPORTS MEDICINE, Knot Push.. | 1 0.90 51.35 C-Plus'' 10mm x 12mm Webless implants.. | 1 0.90 52.25 Carestream DRX-Revolution Mobile X-Ra.. | 1 0.90 53.15 Carisoprodol Tablets, USP, CIV, 350 m.. | 1 0.90 54.05 Catalys Precision Laser System (Unite.. | 1 0.90 54.95 Creole & Company Creole Bisque, NET W.. | 1 0.90 55.86 EOS System X- ray beam Digital radi.. | 1 0.90 56.76 EstroPlus Maximum Strength Menopause .. | 1 0.90 57.66 FIBRICOR (fenofibric acid) Tablets, 1.. | 1 0.90 58.56 Fenofibric Acid, immediate release ta.. | 1 0.90 59.46 Fenofibric Acid, immediate release ta.. | 1 0.90 60.36 Fresenius 2008 Series Hemodialysis Ma.. | 1 0.90 61.26 HB1C Flex(R) Reagent Cartridge (DF105.. | 1 0.90 62.16 HbA1c Flex(R) reagent cartridge (K310.. | 1 0.90 63.06 Hood brand Fat Free Chocolate Milk, .. | 1 0.90 63.96 IMT Wellness Legume Digest 2.0** Diet.. | 1 0.90 64.86 IMT Wellness Tribulus Supreme 2.0** G.. | 1 0.90 65.77 Integra Large Rickham -Style Reservoi.. | 1 0.90 66.67 Integra Small Rickham -Style Reservoi.. | 1 0.90 67.57 Jelco Smiths Medical Hypodermic Needl.. | 1 0.90 68.47 Jelco Smiths Medical Hypodermic Needl.. | 1 0.90 69.37 Jelco Smiths Medical Hypodermic Needl.. | 1 0.90 70.27 Jelco Smiths Medical Hypodermic Needl.. | 1 0.90 71.17 Jelco Smiths Medical Hypodermic Needl.. | 1 0.90 72.07 Multiples Anspach Micro Curved Attach.. | 1 0.90 72.97 NanoClave Connector, Part No. A1000, .. | 1 0.90 73.87 NanoClave Stopcock, Part No. A1000, I.. | 1 0.90 74.77 Nova StatStrip/StatSensor Hospital Bl.. | 1 0.90 75.68 On Site Gas Systems POGS 33C Portable.. | 1 0.90 76.58 Organic Almonds: Baugher Ranch Organi.. | 1 0.90 77.48 PGE 20 mcg/mL Injectable, 10 mL, and .. | 1 0.90 78.38 Papaverine/Phentolamine 30 mg/mL/2.0 .. | 1 0.90 79.28 PedFuse Bone Probe; Part: SI81008 spi.. | 1 0.90 80.18 Product Brand Name(s): Innovacon Oral.. | 1 0.90 81.08 Puritan Bennett 840 ventilator system.. | 1 0.90 81.98 Quad Mix Injectable, 5 mL, Rx Only, T.. | 1 0.90 82.88 REF 42-411571 QTY 1 CATALOG CAUTION.. | 1 0.90 83.78 SOLAR 8000 AND TRANSPORT PRO WITH PAT.. | 1 0.90 84.68 Safeway Kitchens In Shell Edamame; Ne.. | 1 0.90 85.59 Sandel Healthcare Safety Devices Weig.. | 1 0.90 86.49 Sandel Healthcare Safety Devices Weig.. | 2 1.80 88.29 Sandel Healthcare Safety Devices Weig.. | 1 0.90 89.19 Sandel Healthcare Safety Devices Weig.. | 1 0.90 90.09 Sandel Healthcare Safety Devices Weig.. | 1 0.90 90.99 Sandel Healthcare Safety Devices Weig.. | 1 0.90 91.89 Spectre Wireless Footswitch/Handswitc.. | 1 0.90 92.79 Stryker Color Cuff, REF 5921-034-135 .. | 1 0.90 93.69 Super Triple Mix Injectable, (aka Dr .. | 1 0.90 94.59 Terrain Zyme LGS-Zyme (Z-12), Enzyme-.. | 1 0.90 95.50 Terrain Zyme Myco-Zyme (Z-13), Enzyme.. | 1 0.90 96.40 The Propaq LT Series monitors. Model .. | 1 0.90 97.30 The Vantage Digital Panoramic System .. | 1 0.90 98.20 Tracer IV wheelchairs, Heavy duty man.. | 1 0.90 99.10 Triple Mix Injectable (aka Dr Ungers .. | 1 0.90 100.00 ----------------------------------------+----------------------------------- Total | 111 100.00 Frequencies for codeinfo variable in enfrep20140115 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- 1091271, 1094671, 1104165, 1104631, 1.. | 1 0.90 0.90 1094085, 1101479, 1101647, 1102403, 1.. | 1 0.90 1.80 3FN0981 (Exp 04/15), 3FN1338 (Exp 04/.. | 1 0.90 2.70 510 K exempt Device Listing Number D1.. | 1 0.90 3.60 510 K exempt Device Listing Number D1.. | 1 0.90 4.50 510 K exempt Device Listing Number D1.. | 1 0.90 5.41 510 K exempt Device Listing Number D1.. | 1 0.90 6.31 510 K exempt Device Listing Number D1.. | 1 0.90 7.21 510 K exempt Device Listing Number D1.. | 1 0.90 8.11 510 K exempt Device Listing Number D1.. | 1 0.90 9.01 54179002, 54179003, 54179004 | 1 0.90 9.91 54217002 | 1 0.90 10.81 All Lots | 5 4.50 15.32 All Lots for MCA - MICRO CURVED ATTA.. | 1 0.90 16.22 All serial numbers | 2 1.80 18.02 All units shipped prior to Octotber 1.. | 1 0.90 18.92 B3303-T, Lot # 2791243. | 1 0.90 19.82 Best before May 21, 2015: Packed on N.. | 1 0.90 20.72 Catalog #25-3011, Lot #1049402 | 1 0.90 21.62 Catalog number DF105A (Siemens Materi.. | 1 0.90 22.52 Catalog number K3105A (Siemens Materi.. | 1 0.90 23.42 DRX Revolution Mobile X-Ray Systems m.. | 1 0.90 24.32 EOS System | 1 0.90 25.23 Hi-Line XXS handpiece; Part Number -.. | 1 0.90 26.13 Item # A1003, Lot # 2773812. | 1 0.90 27.03 Item # A1099, Lot # 2791393. | 1 0.90 27.93 Item # B3304-T, Lot # 2791244. | 1 0.90 28.83 Item # B33071-T, Lot # 2791245. | 1 0.90 29.73 Item # B33101-T, Lot # 2791358. | 1 0.90 30.63 Item #011-A1096, Lot # 2796668. | 1 0.90 31.53 Item No. 011-A1094. Lot No. 2776971,.. | 1 0.90 32.43 Item No. 011-A1095. Lot No. 2776972,.. | 1 0.90 33.33 Item No. 011-A1097. Lot No. 2781155,.. | 1 0.90 34.23 Item No. SC124. Lot No. 2774006, 27.. | 1 0.90 35.14 Lot # 130401 | 1 0.90 36.04 Lot # 130444 | 1 0.90 36.94 Lot # 244152A, exp 01/15. | 1 0.90 37.84 Lot 094929 | 1 0.90 38.74 Lot 50731155 Color code Purple | 1 0.90 39.64 Lot 6561703, exp. 03/14 | 1 0.90 40.54 Lot No. 2740579 2767063 2771738 | 1 0.90 41.44 Lot No. 2764552 | 1 0.90 42.34 Lot No. 2764741 | 1 0.90 43.24 Lot No. 2766916 2781527 2776455 27.. | 1 0.90 44.14 Lot No. 2767012 | 1 0.90 45.05 Lot No. 2767356 | 1 0.90 45.95 Lot No. 2767357 | 1 0.90 46.85 Lot No. 2767359 | 1 0.90 47.75 Lot No. 2767361 | 1 0.90 48.65 Lot No. 2767362 2782698 | 1 0.90 49.55 Lot No. 2767364 | 1 0.90 50.45 Lot No. 2767365 | 1 0.90 51.35 Lot No. 2767366 | 1 0.90 52.25 Lot No. 2767368 | 1 0.90 53.15 Lot No. 2767371 | 1 0.90 54.05 Lot No. 2767372 | 1 0.90 54.95 Lot No. 2767374 | 1 0.90 55.86 Lot No. 2767375 | 1 0.90 56.76 Lot No. 2767376 | 1 0.90 57.66 Lot No. 2770580 2774284 2777867 27.. | 1 0.90 58.56 Lot No. 2770581 2774286 2777870 27.. | 1 0.90 59.46 Lot No. 2773045 | 1 0.90 60.36 Lot No. 2773046 | 1 0.90 61.26 Lot No. 2773047 | 1 0.90 62.16 Lot No. 2773123 2777666 2781424 | 1 0.90 63.06 Lot No. 2773810 2777115 2781555 | 1 0.90 63.96 Lot No. 2773813 | 1 0.90 64.86 Lot No. 2774004 2776121 2778498 27.. | 1 0.90 65.77 Lot No. 2776452 | 1 0.90 66.67 Lot No. 2776502 | 1 0.90 67.57 Lot No. 2777116 | 1 0.90 68.47 Lot No. 2778180 | 1 0.90 69.37 Lot No. 2781528 | 1 0.90 70.27 Lot No. 2781529 | 1 0.90 71.17 Lot No. 2784698 | 1 0.90 72.07 Lot No. 2784699 | 1 0.90 72.97 Lot No. 2788003 | 1 0.90 73.87 Lot No. 2788311 | 1 0.90 74.77 Lot No. 34-892-HE | 1 0.90 75.68 Lot Number: 2357318 | 1 0.90 76.58 Lot Numbers: 2330832, 2336493, 234870.. | 1 0.90 77.48 Lot Numbers: 2340530, 2344163, 235309.. | 1 0.90 78.38 Lot Numbers: 2356156, 2358706 | 1 0.90 79.28 Lot Numbers: 2358702 | 1 0.90 80.18 Lot number BR08-13A23-1333803; Expira.. | 1 0.90 81.08 Lot/Unit Codes: DSD-765-011 (Alere PN.. | 1 0.90 81.98 Lot: 012212-001 | 1 0.90 82.88 Lots 6504705, 6504706 exp. 05/14 | 1 0.90 83.78 Mfg Lot or Serial # SA307140598GA SA3.. | 1 0.90 84.68 None, the product is not lot coded | 1 0.90 85.59 SERIAL NUMBERS OF DEVICES DISTRIBUTED.. | 1 0.90 86.49 Sell by Date: DEC 31 2014 xx:xx 42-2.. | 1 0.90 87.39 Serial # 1934, 3135, 50229989-3, and .. | 1 0.90 88.29 Serial # 50152011-14 (B-Blue-S) Seria.. | 1 0.90 89.19 Serial #'s: 11HM005144, 11IM031276-11.. | 1 0.90 90.09 Serial Number 31496602 | 1 0.90 90.99 Serial Number F37306977201 | 1 0.90 91.89 Serial Number G11307654403 | 1 0.90 92.79 Serial Number MM900 | 1 0.90 93.69 Serial Numbers: 4220FA 4221FA 4222F.. | 1 0.90 94.59 Serial numbers NS 10324 through NS 10.. | 1 0.90 95.50 Software Part number 4-070212-85, rev.. | 1 0.90 96.40 Three lots of the 10 oz. pacakges, an.. | 1 0.90 97.30 Vantage Panoramic X-Ray System firmwa.. | 1 0.90 98.20 lot 6581105 & 6581106 exp. 07/15, and.. | 1 0.90 99.10 part numbers: 30-CW-1012-5, 30-CW-101.. | 1 0.90 100.00 ----------------------------------------+----------------------------------- Total | 111 100.00 Frequencies for codeinfocontinued variable in enfrep20140115 dataset : Code Info (Continued) | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 109 98.20 98.20 KA022264, KA022265, KA022266, KA0222.. | 1 0.90 99.10 SA307483754GA SA307483756GA SA307483.. | 1 0.90 100.00 ----------------------------------------+----------------------------------- Total | 111 100.00 Frequencies for productquantity variable in enfrep20140115 dataset : Product Quantity | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 4 3.60 3.60 1 B-Blue-S and 1 B-Green | 1 0.90 4.50 1203 - 96 cases (4128 units) ; 1553.. | 1 0.90 5.41 1 | 1 0.90 6.31 1 unit | 1 0.90 7.21 1,224 | 1 0.90 8.11 10,400 units | 1 0.90 9.01 100 | 1 0.90 9.91 100 units | 3 2.70 12.61 108000 | 1 0.90 13.51 11 units | 1 0.90 14.41 11006 Total | 2 1.80 16.22 111,504 units US and 3,638 Canada and.. | 1 0.90 17.12 12 | 1 0.90 18.02 1256 bottles | 1 0.90 18.92 13 cases (312 units); 24 cases (1176 .. | 1 0.90 19.82 13 devices | 1 0.90 20.72 1300 Tribulus | 1 0.90 21.62 1300 units | 1 0.90 22.52 14 | 1 0.90 23.42 15 cases (1440 units); 96 cases (96 .. | 1 0.90 24.32 150 units | 1 0.90 25.23 16,756 US, 39,372 OUS | 1 0.90 26.13 1666 Legume | 1 0.90 27.03 17,444 (11,418 units US, 6,026 units .. | 1 0.90 27.93 1906 | 1 0.90 28.83 194 packages | 1 0.90 29.73 196 cases of 12. x 10 oz, sample siz.. | 1 0.90 30.63 198 units | 1 0.90 31.53 2,785 | 1 0.90 32.43 2000 units | 1 0.90 33.33 22 EOS systems are installed in US | 1 0.90 34.23 22 cases (12 x 3 lb bags per case) | 1 0.90 35.14 22 cases of 20 units | 1 0.90 36.04 2250 units | 1 0.90 36.94 227 Wheelchairs | 1 0.90 37.84 25 units | 1 0.90 38.74 250 | 1 0.90 39.64 250 units | 3 2.70 42.34 280,710 | 1 0.90 43.24 2800 units | 1 0.90 44.14 3 Vials | 1 0.90 45.05 310 systerms domestically | 1 0.90 45.95 363015 | 1 0.90 46.85 4 ( BLACKMAX-N) and 1 (Foot Control) | 1 0.90 47.75 4,439 bottles | 1 0.90 48.65 4000 units | 10 9.01 57.66 4150 | 1 0.90 58.56 48 cases (384 units) | 1 0.90 59.46 5 boxes (50 units) | 1 0.90 60.36 50 | 2 1.80 62.16 50 cases (4800 units); 96 cases (576 .. | 1 0.90 63.06 50 units | 8 7.21 70.27 500 units | 9 8.11 78.38 506925 | 1 0.90 79.28 54000 | 1 0.90 80.18 579 bottles | 1 0.90 81.08 58 units | 1 0.90 81.98 6,734 units | 1 0.90 82.88 6,824 imits (4,7324 in USA / 2,100 Fo.. | 1 0.90 83.78 6003 units total (1715 units in the U.. | 1 0.90 84.68 68 | 1 0.90 85.59 68,534 (units/eaches) | 1 0.90 86.49 69100 units | 1 0.90 87.39 700 units | 1 0.90 88.29 7150 units | 1 0.90 89.19 750 | 1 0.90 90.09 76 | 1 0.90 90.99 78 (39 in US, 39 internationally) | 1 0.90 91.89 78 packages | 1 0.90 92.79 80 cases (25 lbs per case | 1 0.90 93.69 800 | 1 0.90 94.59 92 units | 1 0.90 95.50 93700 | 1 0.90 96.40 96 cases (1920 units) | 1 0.90 97.30 96 cases (288 units) | 1 0.90 98.20 976 | 1 0.90 99.10 est. 200,000 | 1 0.90 100.00 ----------------------------------------+----------------------------------- Total | 111 100.00 Frequencies for reasonforrecall variable in enfrep20140115 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- 2008 Series Hemodialysis Machines com.. | 1 0.90 0.90 A sharp edge on the cannulated tip of.. | 1 0.90 1.80 Alere initiated this recall of certai.. | 1 0.90 2.70 An error was identified in the Real T.. | 1 0.90 3.60 Anspach was contacted by a hospital t.. | 2 1.80 5.41 As the result of a recent internal re.. | 1 0.90 6.31 Bone Probes used to create a pathway .. | 1 0.90 7.21 Certain lots of the Aesculap Hi Line .. | 1 0.90 8.11 Covidien is conducting a voluntary fi.. | 1 0.90 9.01 During a recent review of documentati.. | 1 0.90 9.91 EOS imaging discovered during product.. | 1 0.90 10.81 GE Healthcare has recently become awa.. | 1 0.90 11.71 Heat exchanger hose becomes weak and .. | 1 0.90 12.61 ICU Medical is recalling certain lots.. | 50 45.05 57.66 Innovative Labs, LLC. has recalled tw.. | 2 1.80 59.46 Integra became aware through an adver.. | 1 0.90 60.36 Integra became aware through an adver.. | 1 0.90 61.26 It was discovered that Carestream rec.. | 1 0.90 62.16 Labeling: Incorrect Instructions: The.. | 1 0.90 63.06 Labeling: Incorrect instructions; an .. | 1 0.90 63.96 Lack of Assurance of Sterility; All l.. | 5 4.50 68.47 Positive bias on the lots listed comp.. | 2 1.80 70.27 Potential for Chloramphenicol contami.. | 2 1.80 72.07 Potential for metal fragments in prod.. | 1 0.90 72.97 Potential for unexpected heating of t.. | 1 0.90 73.87 Potential presence of Chloramphenicol.. | 1 0.90 74.77 Presence of Foreign Substance; metal .. | 1 0.90 75.68 Product labeled with an extended sell.. | 1 0.90 76.58 Product on hold pending FDA testing t.. | 1 0.90 77.48 Product which contains milk, soy, and.. | 1 0.90 78.38 Revised Battery Instructions for Remo.. | 1 0.90 79.28 Select lots of SANDEL Weighted Safety.. | 7 6.31 85.59 Shipped femur guide contained a non-c.. | 1 0.90 86.49 The Color Cuff Sterile Disposable Tou.. | 1 0.90 87.39 The firm Anspach Effort of Palm Beach.. | 4 3.60 90.99 The product was not labeled with ingr.. | 1 0.90 91.89 The reason for this recall is an erro.. | 1 0.90 92.79 The wheels on Tracer IV wheelchairs (.. | 1 0.90 93.69 TransAmerican Medical Imaging is reca.. | 1 0.90 94.59 Visible orange/ brown particulate on .. | 5 4.50 99.10 Welch Allyn will update Propaq 802 Se.. | 1 0.90 100.00 ----------------------------------------+----------------------------------- Total | 111 100.00 Frequencies for recallinitiationdate variable in enfrep20140115 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 16apr2012 | 1 0.90 0.90 11jun2012 | 2 1.80 2.70 26oct2012 | 1 0.90 3.60 27feb2013 | 3 2.70 6.31 22apr2013 | 2 1.80 8.11 25apr2013 | 4 3.60 11.71 03jun2013 | 1 0.90 12.61 06jun2013 | 1 0.90 13.51 10jul2013 | 5 4.50 18.02 22aug2013 | 1 0.90 18.92 29aug2013 | 1 0.90 19.82 11sep2013 | 1 0.90 20.72 20sep2013 | 1 0.90 21.62 07oct2013 | 1 0.90 22.52 10oct2013 | 1 0.90 23.42 14oct2013 | 2 1.80 25.23 18oct2013 | 5 4.50 29.73 01nov2013 | 2 1.80 31.53 07nov2013 | 1 0.90 32.43 12nov2013 | 8 7.21 39.64 13nov2013 | 2 1.80 41.44 21nov2013 | 2 1.80 43.24 25nov2013 | 1 0.90 44.14 26nov2013 | 1 0.90 45.05 05dec2013 | 1 0.90 45.95 06dec2013 | 1 0.90 46.85 09dec2013 | 2 1.80 48.65 16dec2013 | 2 1.80 50.45 18dec2013 | 2 1.80 52.25 19dec2013 | 1 0.90 53.15 20dec2013 | 1 0.90 54.05 23dec2013 | 1 0.90 54.95 24dec2013 | 50 45.05 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for recallinitiationdatestr variable in enfrep20140115 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 02/27/2013 | 3 2.70 2.70 04/16/2012 | 1 0.90 3.60 04/22/2013 | 2 1.80 5.41 04/25/2013 | 4 3.60 9.01 06/03/2013 | 1 0.90 9.91 06/06/2013 | 1 0.90 10.81 06/11/2012 | 2 1.80 12.61 07/10/2013 | 5 4.50 17.12 08/22/2013 | 1 0.90 18.02 08/29/2013 | 1 0.90 18.92 09/11/2013 | 1 0.90 19.82 09/20/2013 | 1 0.90 20.72 10/07/2013 | 1 0.90 21.62 10/10/2013 | 1 0.90 22.52 10/14/2013 | 2 1.80 24.32 10/18/2013 | 5 4.50 28.83 10/26/2012 | 1 0.90 29.73 11/01/2013 | 2 1.80 31.53 11/07/2013 | 1 0.90 32.43 11/12/2013 | 8 7.21 39.64 11/13/2013 | 2 1.80 41.44 11/21/2013 | 2 1.80 43.24 11/25/2013 | 1 0.90 44.14 11/26/2013 | 1 0.90 45.05 12/05/2013 | 1 0.90 45.95 12/06/2013 | 1 0.90 46.85 12/09/2013 | 2 1.80 48.65 12/16/2013 | 2 1.80 50.45 12/18/2013 | 2 1.80 52.25 12/19/2013 | 1 0.90 53.15 12/20/2013 | 1 0.90 54.05 12/23/2013 | 1 0.90 54.95 12/24/2013 | 50 45.05 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for reportdate variable in enfrep20140115 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 15jan2014 | 111 100.00 100.00 ------------+----------------------------------- Total | 111 100.00 Frequencies for reportdatestr variable in enfrep20140115 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 01/15/2014 | 111 100.00 100.00 ------------+----------------------------------- Total | 111 100.00 by Jean Roth , jroth@nber.org , 18 Dec 2015