Frequencies for enfrep20141007 dataset : by Jean Roth , jroth@nber.org , 18 Dec 2015 Frequencies for producttype variable in enfrep20141007 dataset : Product | Type | Freq. Percent Cum. ------------+----------------------------------- Biologics | 4 5.56 5.56 Cosmetics | 1 1.39 6.94 Devices | 37 51.39 58.33 Drugs | 12 16.67 75.00 Food | 16 22.22 97.22 Veterinary | 2 2.78 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for eventid variable in enfrep20141007 dataset : Event ID | Freq. Percent Cum. ------------+----------------------------------- 67687 | 1 1.39 1.39 67689 | 1 1.39 2.78 68014 | 2 2.78 5.56 68218 | 3 4.17 9.72 68329 | 1 1.39 11.11 68417 | 3 4.17 15.28 68579 | 1 1.39 16.67 68725 | 10 13.89 30.56 68932 | 2 2.78 33.33 68962 | 10 13.89 47.22 68969 | 1 1.39 48.61 68998 | 1 1.39 50.00 69011 | 1 1.39 51.39 69016 | 1 1.39 52.78 69024 | 1 1.39 54.17 69025 | 2 2.78 56.94 69031 | 1 1.39 58.33 69039 | 1 1.39 59.72 69042 | 1 1.39 61.11 69053 | 1 1.39 62.50 69060 | 2 2.78 65.28 69063 | 1 1.39 66.67 69064 | 1 1.39 68.06 69084 | 2 2.78 70.83 69094 | 1 1.39 72.22 69122 | 1 1.39 73.61 69132 | 1 1.39 75.00 69139 | 1 1.39 76.39 69151 | 1 1.39 77.78 69164 | 1 1.39 79.17 69192 | 1 1.39 80.56 69194 | 1 1.39 81.94 69213 | 1 1.39 83.33 69235 | 1 1.39 84.72 69237 | 2 2.78 87.50 69258 | 4 5.56 93.06 69267 | 2 2.78 95.83 69285 | 1 1.39 97.22 69303 | 1 1.39 98.61 69322 | 1 1.39 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for status variable in enfrep20141007 dataset : Status | Freq. Percent Cum. ------------+----------------------------------- Ongoing | 68 94.44 94.44 Terminated | 4 5.56 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for recallingfirm variable in enfrep20141007 dataset : Recalling Firm | Freq. Percent Cum. ----------------------------------------+----------------------------------- AbbVie Inc | 1 1.39 1.39 Actavis Laboratories, FL, Inc. | 2 2.78 4.17 Apollo Endosurgery Inc | 1 1.39 5.56 Avera McKennan Hospital & University .. | 2 2.78 8.33 Bar Harbor Jam Company | 3 4.17 12.50 Baro-Therapies, Inc | 1 1.39 13.89 Baxter Healthcare Corp. | 3 4.17 18.06 Bimeda MTC Animal Health Inc. | 1 1.39 19.44 Blood Assurance Inc | 1 1.39 20.83 Boskovich Farms, Inc | 2 2.78 23.61 Cubist Pharmaceuticals, Inc. | 1 1.39 25.00 DCI Biologicals Orlando LLC | 1 1.39 26.39 Dd Traders Inc | 1 1.39 27.78 ELITech Clinical Systems SAS | 1 1.39 29.17 Eugene Oregon, Inc. | 3 4.17 33.33 GE Healthcare, LLC | 1 1.39 34.72 Gendex Corp | 1 1.39 36.11 Hospira Inc. | 1 1.39 37.50 Instrumed International, Inc. | 10 13.89 51.39 Intuitive Surgical, Inc. | 1 1.39 52.78 Invivo Corporation | 1 1.39 54.17 KCI USA, Inc. | 1 1.39 55.56 Lumenis, Inc. | 1 1.39 56.94 Nanosphere, Inc. | 2 2.78 59.72 New England Home Therapies, Inc | 1 1.39 61.11 Ortho-Clinical Diagnostics | 1 1.39 62.50 Pegasus Laboratories, Inc. | 1 1.39 63.89 Philips Medical Systems (Cleveland) Inc | 1 1.39 65.28 Sagent Pharmaceuticals Inc | 1 1.39 66.67 Siemens Healthcare Diagnostics | 2 2.78 69.44 Siemens Healthcare Diagnostics, Inc. | 1 1.39 70.83 Siemens Medical Solutions USA, Inc | 4 5.56 76.39 Siemens Medical Solutions USA, Inc. | 2 2.78 79.17 St. Jude Medical, Inc. | 2 2.78 81.94 TJs Place | 1 1.39 83.33 Teleflex Medical | 1 1.39 84.72 Tradewind Foods de Puerto Rico Inc. | 10 13.89 98.61 Zimmer, Inc. | 1 1.39 100.00 ----------------------------------------+----------------------------------- Total | 72 100.00 Frequencies for city variable in enfrep20141007 dataset : City | Freq. Percent Cum. ----------------+----------------------------------- Bar Harbor | 3 4.17 4.17 Bayamon | 10 13.89 18.06 Cambridge | 1 1.39 19.44 Chattanooga | 1 1.39 20.83 Cleveland | 1 1.39 22.22 Davie | 2 2.78 25.00 Deerfield | 2 2.78 27.78 Durham | 1 1.39 29.17 Hatfield | 1 1.39 30.56 Hoffman Estates | 2 2.78 33.33 Kirkland | 1 1.39 34.72 Lake Forest | 1 1.39 36.11 Leawood | 1 1.39 37.50 Levittown | 3 4.17 41.67 Lexington | 1 1.39 43.06 Malvern | 4 5.56 48.61 Miramar Beach | 1 1.39 50.00 Newark | 1 1.39 51.39 North Chicago | 1 1.39 52.78 Northbrook | 2 2.78 55.56 Orlando | 2 2.78 58.33 Oxnard | 2 2.78 61.11 Pensacola | 1 1.39 62.50 Plano | 2 2.78 65.28 Rochester | 1 1.39 66.67 Round Lake | 1 1.39 68.06 SEES | 1 1.39 69.44 Salt Lake City | 1 1.39 70.83 San Antonio | 1 1.39 72.22 Schaumburg | 11 15.28 87.50 Sioux Falls | 2 2.78 90.28 Southborough | 1 1.39 91.67 Sunnyvale | 1 1.39 93.06 Tarrytown | 2 2.78 95.83 Warsaw | 1 1.39 97.22 Waukesha | 1 1.39 98.61 West Lake Hills | 1 1.39 100.00 ----------------+----------------------------------- Total | 72 100.00 Frequencies for state variable in enfrep20141007 dataset : State | Freq. Percent Cum. ------------+----------------------------------- | 2 2.78 2.78 CA | 3 4.17 6.94 DE | 1 1.39 8.33 FL | 6 8.33 16.67 IL | 20 27.78 44.44 IN | 1 1.39 45.83 KS | 1 1.39 47.22 MA | 2 2.78 50.00 ME | 3 4.17 54.17 NC | 1 1.39 55.56 NY | 3 4.17 59.72 OH | 1 1.39 61.11 PA | 8 11.11 72.22 PR | 10 13.89 86.11 SD | 2 2.78 88.89 TN | 1 1.39 90.28 TX | 4 5.56 95.83 UT | 1 1.39 97.22 WA | 1 1.39 98.61 WI | 1 1.39 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for country variable in enfrep20141007 dataset : Country | Freq. Percent Cum. ------------+----------------------------------- CA | 1 1.39 1.39 FR | 1 1.39 2.78 US | 70 97.22 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for voluntarymandated variable in enfrep20141007 dataset : Voluntary/Mandated | Freq. Percent Cum. --------------------------+----------------------------------- Voluntary: Firm Initiated | 72 100.00 100.00 --------------------------+----------------------------------- Total | 72 100.00 Frequencies for initialfirmnotificationofconsign variable in enfrep20141007 dataset : Initial Firm Notification of Consignee | or Public | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 1 1.39 1.39 E-Mail | 3 4.17 5.56 FAX | 4 5.56 11.11 Letter | 51 70.83 81.94 Press Release | 2 2.78 84.72 Telephone | 3 4.17 88.89 Two or more of the following: Email, .. | 7 9.72 98.61 Visit | 1 1.39 100.00 ----------------------------------------+----------------------------------- Total | 72 100.00 Frequencies for distributionpattern variable in enfrep20141007 dataset : Distribution Pattern | Freq. Percent Cum. ----------------------------------------+----------------------------------- CA | 2 2.78 2.78 CA, FL, GA, KY, MO, NY, PA, TX, and VA | 1 1.39 4.17 Distributed in the states of Californ.. | 1 1.39 5.56 Distributed in the states of Texas an.. | 2 2.78 8.33 Distribution was made to AL, AK, AR, .. | 1 1.39 9.72 Domestic to Puerto Rico and USA (NY,.. | 10 13.89 23.61 Nationwide | 3 4.17 27.78 Nationwide Foreign: Israel, Taiwan | 1 1.39 29.17 Nationwide Distribution | 1 1.39 30.56 Nationwide Distribution - US includin.. | 4 5.56 36.11 Nationwide Distribution in the states.. | 9 12.50 48.61 Nationwide Distribution including the.. | 1 1.39 50.00 Nationwide and Canada | 1 1.39 51.39 Nationwide and Puerto Rico | 2 2.78 54.17 Product was distributed in ME, NH, an.. | 3 4.17 58.33 South Dakota; Kentucky | 2 2.78 61.11 Tennessee | 1 1.39 62.50 To retailers in MD, TX, FL, PA, IL, N.. | 3 4.17 66.67 US Nationwide Distribution | 1 1.39 68.06 US Nationwide Distribution in the sta.. | 1 1.39 69.44 US: IA, MN | 1 1.39 70.83 US: Nationwide | 1 1.39 72.22 US: Nationwide in the states of: (AL.. | 1 1.39 73.61 US: New England | 1 1.39 75.00 United Kingdom | 1 1.39 76.39 Washington State | 1 1.39 77.78 Worldwide Distribution - US Nationwid.. | 1 1.39 79.17 Worldwide Distribution - US Nationwid.. | 1 1.39 80.56 Worldwide Distribution - US Nationwid.. | 1 1.39 81.94 Worldwide Distribution - US including.. | 1 1.39 83.33 Worldwide Distribution - US nationwid.. | 1 1.39 84.72 Worldwide Distribution - USA (Nationw.. | 1 1.39 86.11 Worldwide Distribution - USA (nationw.. | 1 1.39 87.50 Worldwide Distribution - USA includin.. | 2 2.78 90.28 Worldwide Distribution -- USA and Can.. | 1 1.39 91.67 Worldwide Distribution including the .. | 2 2.78 94.44 Worldwide Distribution: US (nationwid.. | 1 1.39 95.83 Worldwide Distribution: US distributi.. | 1 1.39 97.22 Worldwide Distribution:US (Nationwide.. | 2 2.78 100.00 ----------------------------------------+----------------------------------- Total | 72 100.00 Frequencies for recallnumber variable in enfrep20141007 dataset : Recall | Number | Freq. Percent Cum. ------------+----------------------------------- B-0827-14 | 1 1.39 1.39 B-0828-14 | 1 1.39 2.78 B-0892-14 | 1 1.39 4.17 B-0970-14 | 1 1.39 5.56 D-0001-2015 | 1 1.39 6.94 D-0002-2015 | 1 1.39 8.33 D-0003-2015 | 1 1.39 9.72 D-0004-2015 | 1 1.39 11.11 D-1610-2014 | 1 1.39 12.50 D-1611-2014 | 1 1.39 13.89 D-1613-2014 | 1 1.39 15.28 D-1614-2014 | 1 1.39 16.67 D-1615-2014 | 1 1.39 18.06 D-1616-2014 | 1 1.39 19.44 D-1617-2014 | 1 1.39 20.83 D1612-2014 | 1 1.39 22.22 F-2523-2014 | 1 1.39 23.61 F-2524-2014 | 1 1.39 25.00 F-2525-2014 | 1 1.39 26.39 F-2526-2014 | 1 1.39 27.78 F-2527-2014 | 1 1.39 29.17 F-2528-2014 | 1 1.39 30.56 F-2529-2014 | 1 1.39 31.94 F-2530-2014 | 1 1.39 33.33 F-2531-2014 | 1 1.39 34.72 F-2532-2014 | 1 1.39 36.11 F-2533-2014 | 1 1.39 37.50 F-2534-2014 | 1 1.39 38.89 F-2535-2014 | 1 1.39 40.28 F-2536-2014 | 1 1.39 41.67 F-2537-2014 | 1 1.39 43.06 F-2538-2014 | 1 1.39 44.44 F-2539-2014 | 1 1.39 45.83 V-166-2014 | 1 1.39 47.22 V-167-2014 | 1 1.39 48.61 Z-0001-2015 | 1 1.39 50.00 Z-0002-2015 | 1 1.39 51.39 Z-0003-2015 | 1 1.39 52.78 Z-0004-2015 | 1 1.39 54.17 Z-0005-2015 | 1 1.39 55.56 Z-0006-2015 | 1 1.39 56.94 Z-0007-2015 | 1 1.39 58.33 Z-0009-2015 | 1 1.39 59.72 Z-0010-2015 | 1 1.39 61.11 Z-2711-2014 | 1 1.39 62.50 Z-2712-2014 | 1 1.39 63.89 Z-2713-2014 | 1 1.39 65.28 Z-2714-2014 | 1 1.39 66.67 Z-2715-2014 | 1 1.39 68.06 Z-2716-2014 | 1 1.39 69.44 Z-2717-2014 | 1 1.39 70.83 Z-2718-2014 | 1 1.39 72.22 Z-2719-2014 | 1 1.39 73.61 Z-2720-2014 | 1 1.39 75.00 Z-2721-2014 | 1 1.39 76.39 Z-2722-2014 | 1 1.39 77.78 Z-2723-2014 | 1 1.39 79.17 Z-2724-2014 | 1 1.39 80.56 Z-2725-2014 | 1 1.39 81.94 Z-2726-2014 | 1 1.39 83.33 Z-2727-2014 | 1 1.39 84.72 Z-2728-2014 | 1 1.39 86.11 Z-2729-2014 | 1 1.39 87.50 Z-2730-2014 | 1 1.39 88.89 Z-2731-2014 | 1 1.39 90.28 Z-2732-2014 | 1 1.39 91.67 Z-2733-2014 | 1 1.39 93.06 Z-2734-2014 | 1 1.39 94.44 Z-2735-2014 | 1 1.39 95.83 Z-2736-2014 | 1 1.39 97.22 Z-2737-2014 | 1 1.39 98.61 Z-2738-2014 | 1 1.39 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for classification variable in enfrep20141007 dataset : Classificat | ion | Freq. Percent Cum. ------------+----------------------------------- Class I | 10 13.89 13.89 Class II | 60 83.33 97.22 Class III | 2 2.78 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for productdescription variable in enfrep20141007 dataset : Product Description | Freq. Percent Cum. ----------------------------------------+----------------------------------- Goya Black Beans Frijoles Negros 15.. | 1 1.39 1.39 Goya Chick Peas Garbanzos 15.5 oz. (.. | 1 1.39 2.78 2-5 lb. clear plastic overwrapped bla.. | 1 1.39 4.17 2/24 ounce clear plastic bags of 3/8 .. | 1 1.39 5.56 ADVIA Centaur Immunoassay System (inc.. | 1 1.39 6.94 ADVIA Centaur XP Immunoassay System (.. | 1 1.39 8.33 AFRICAN BLACK ANT, 2800 mg, 6 capsule.. | 1 1.39 9.72 ASSEMBLY, PATIENT SIDE CART, PS4000 u.. | 1 1.39 11.11 All sterile drugs compounded between .. | 1 1.39 12.50 Array LaserLink, Manufactured by Lume.. | 1 1.39 13.89 BAR HARBOR JAM COMPANY Maine Old Fash.. | 1 1.39 15.28 BAR HARBOR JAM COMPANY Maine Wild Blu.. | 1 1.39 16.67 BAR HARBOR JAM COMPANY Maine Wild Blu.. | 1 1.39 18.06 Basil Pesto Pasta packaged in a non-f.. | 1 1.39 19.44 Black Ant, 2800 mg, four capsules per.. | 1 1.39 20.83 CREON (pancrelipase) Delayed-Release .. | 1 1.39 22.22 CUBICIN (daptomycin for injection), 5.. | 1 1.39 23.61 CelluTome Epidermal Harvesting System.. | 1 1.39 25.00 DOPamine Hydrochloride and 5% Dextros.. | 1 1.39 26.39 Dianeal Low Calcium (2.5 mEq/L) Perit.. | 1 1.39 27.78 Diclofenac Sodium and Misoprostol Del.. | 1 1.39 29.17 Diclofenac Sodium and Misoprostol Del.. | 1 1.39 30.56 ENVOY 500 AST Reagent Kit, reference .. | 1 1.39 31.94 GE Healthcare Precision 500D, Classic.. | 1 1.39 33.33 Glow OLOGY Renew body butter packaged.. | 1 1.39 34.72 Goya Pink Beans In sauce prepared w.. | 1 1.39 36.11 Goya Black Bean Soup Prepared with O.. | 1 1.39 37.50 Goya Pinto Beans Habichuelas Pintas 1.. | 1 1.39 38.89 Goya Pinto Beans In Sauce prepared wi.. | 1 1.39 40.28 Goya Red Kidney Beans Habichuelas Co.. | 1 1.39 41.67 Goya Small Red Beans Habichuelas Col.. | 1 1.39 43.06 Goya Whole Green Peas Chicharos 15.5 .. | 1 1.39 44.44 Hudson RCI Pediatric Anesthesia Breat.. | 1 1.39 45.83 Ivermax (Ivermectin) 1% sterile solut.. | 1 1.39 47.22 LAP-BAND AP SYSTEM AP Large with Acce.. | 1 1.39 48.61 MOJO RISEN, 650 mg, 2 capsule per pou.. | 1 1.39 50.00 Marcaine (bupivacaine HCl) injection,.. | 1 1.39 51.39 Percutaneous Trial Lead Kit Model 304.. | 1 1.39 52.78 Percutaneous Trial Lead Kit Model 308.. | 1 1.39 54.17 Persona The Personalized Knee System .. | 1 1.39 55.56 Philips Expression MR200 MRI Patient .. | 1 1.39 56.94 Pink Beans sold under two brand names.. | 1 1.39 58.33 Plasma | 1 1.39 59.72 Platelets Pheresis Leukocytes Reduced.. | 1 1.39 61.11 ReBalance Antiprotozoal Oral Suspensi.. | 1 1.39 62.50 Red Blood Cells Leukocytes Reduced | 1 1.39 63.89 Reusable laparoscopic instruments are.. | 10 13.89 77.78 SPECTRUM Pump, Model No. 35700BAX. .. | 1 1.39 79.17 Siemens AXIOM Luminos dRF Max system.. | 1 1.39 80.56 Siemens Dimension Vista CHEM 1 CAL, l.. | 1 1.39 81.94 Siemens Luminos Agile Max system The.. | 1 1.39 83.33 Siemens Uroskop Omnia Max system The.. | 1 1.39 84.72 Siemens Ysio Max system The Ysio Max .. | 1 1.39 86.11 Source Plasma | 1 1.39 87.50 The Ingenuity CT, Ingenuity Core, and.. | 1 1.39 88.89 The Rejuvenator Chamber manufactured .. | 1 1.39 90.28 The Symbia Intevo series consists of .. | 1 1.39 91.67 The Symbia T Series consists of the T.. | 1 1.39 93.06 VITROS Chemistry Products PHYT (Pheny.. | 1 1.39 94.44 Verigene BC-GN Kit (Catalog number 20.. | 1 1.39 95.83 Verigene BC-GP Kit (Catalog number 20.. | 1 1.39 97.22 Zoledronic Acid Injection 5 mg per 10.. | 1 1.39 98.61 eXpertDC intraoral x-ray, models: eXp.. | 1 1.39 100.00 ----------------------------------------+----------------------------------- Total | 72 100.00 Frequencies for codeinfo variable in enfrep20141007 dataset : Code Info | Freq. Percent Cum. ----------------------------------------+----------------------------------- 0825, 0826, 0827, and 0828. Code re.. | 1 1.39 1.39 1) Instrumed Item No.: 250-08570; Car.. | 1 1.39 2.78 1) Instrumed Item No.: 250-08660; Sur.. | 1 1.39 4.17 1) Instrumed Item No.: 250-08680; Bos.. | 1 1.39 5.56 1) Instrumed Item No.: 250-08800; Adl.. | 1 1.39 6.94 1) Instrumed Item No.: 250-08860; Sym.. | 1 1.39 8.33 1) Instrumed Item No.: 250-08930; Amb.. | 1 1.39 9.72 1) Instrumed Item No.: 250-08930; Pil.. | 1 1.39 11.11 1) Instrumed Item No.: 250-08930; Spe.. | 1 1.39 12.50 1) Instrumed Item No.: 250-08930; Sur.. | 1 1.39 13.89 1) Instrumed Item No.: 250-09010; Pho.. | 1 1.39 15.28 1) Symbia Intevo Excel; Product Code:.. | 1 1.39 16.67 1) Symbia T; Product Code: 10275007; .. | 1 1.39 18.06 All Lots, Series and Codes | 1 1.39 19.44 All assembled units since product rel.. | 1 1.39 20.83 All lots | 2 2.78 23.61 All lots | 1 1.39 25.00 All serial numbers. Model Numbers/Sie.. | 1 1.39 26.39 All serial numbers. Model Numbers/Sie.. | 1 1.39 27.78 Batch # 2025 (Lot 4112 and Lot 4113) | 1 1.39 29.17 Expiration dates between 3/5/14 and 3.. | 1 1.39 30.56 Ingenuity CT: 728326 300005,300010,3.. | 1 1.39 31.94 Item Number: 1IVE038, Lot Number: 2E055 | 1 1.39 33.33 L091-EI03712, L091-EI09362. | 1 1.39 34.72 L091-EI03718, L091-EI08269, L-091-EI0.. | 1 1.39 36.11 Lap-Band System AP Standard Catalog N.. | 1 1.39 37.50 Lot # 131110 | 1 1.39 38.89 Lot # 33-545-DD, Exp. 09/15 | 1 1.39 40.28 Lot #: 081753F, 081803F, 081853F, Exp.. | 1 1.39 41.67 Lot #: 1020156; Expiry: 3/31/2016 | 1 1.39 43.06 Lot #: 605956A, 605958A, Exp. 9/30/20.. | 1 1.39 44.44 Lot #: 660513A, Exp. 10/31/2014 | 1 1.39 45.83 Lot #: C940700, C940841, Exp 05/16 | 1 1.39 47.22 Lot 4014, Expiration date 07/2015; Lo.. | 1 1.39 48.61 Lot A 2067 8 BB 08/13/18 | 1 1.39 50.00 Lot A2055 8 BB 08/12/18 and A2055 8 B.. | 1 1.39 51.39 Lot A2062 8 BB 08/15/18 | 1 1.39 52.78 Lot A2420 BB 09/06/18 | 1 1.39 54.17 Lot A2422 8 BB 07/11/18 | 1 1.39 55.56 Lot A2437 8 BB 08/09/18 | 1 1.39 56.94 Lot A2461 8 BB 07/09/18 | 1 1.39 58.33 Lot Number 2613-0150-4913, exp. 15-No.. | 1 1.39 59.72 Lot Numbers: 62155015 62165014 621.. | 1 1.39 61.11 Lot# P303172; Exp. 12/14 | 1 1.39 62.50 Lots A2406 8 BB 07/12/18; A2406 8 BB .. | 1 1.39 63.89 Lots A2466 8 BB 06/21/18 and Lot A246.. | 1 1.39 65.28 Lots: A2402 8 BB 08/08/18; A 2402 8 B.. | 1 1.39 66.67 Material 100077108, Batch 4519182 | 1 1.39 68.06 Material 100077113, Batch 4558337 | 1 1.39 69.44 Mfg Lot or Serial # System ID 0000001.. | 1 1.39 70.83 Model 866120 with the following lots .. | 1 1.39 72.22 Models: eXpert DC, NA, 75 Inch reach;.. | 1 1.39 73.61 NDC 25021-830-82; Lot Numbers and Exp.. | 1 1.39 75.00 OL0399363; | 1 1.39 76.39 PATIENT SIDE CART, PS4000. Part Numb.. | 1 1.39 77.78 Part Number: 20-009-018; Lot Numbers:.. | 1 1.39 79.17 Part Number: 20-009-021; Lot Numbers:.. | 1 1.39 80.56 Part number CT-H25 with the following.. | 1 1.39 81.94 Product Code: 313905, Lot #02F1300085.. | 1 1.39 83.33 Siemens Uroskop Omnia Max system, ma.. | 1 1.39 84.72 Siemens AXIOM Luminos dRF Max system .. | 1 1.39 86.11 Siemens Luminos Agile Max system mate.. | 1 1.39 87.50 Siemens Ysio Max material #s: 1076247.. | 1 1.39 88.89 Software Versions 5.02.06, 6.02.06, a.. | 1 1.39 90.28 UPC Code: 892845001 607 | 1 1.39 91.67 UPC Code: 892845001 614 | 1 1.39 93.06 UPC Code: 892845001621 | 1 1.39 94.44 W043214051674; | 1 1.39 95.83 W116113006606; | 2 2.78 98.61 lot 3GM081, exp. 07-01-2014 | 1 1.39 100.00 ----------------------------------------+----------------------------------- Total | 72 100.00 Frequencies for codeinfocontinued variable in enfrep20141007 dataset : Code Info | (Continued) | Freq. Percent Cum. ------------+----------------------------------- . | 72 100.00 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for productquantity variable in enfrep20141007 dataset : Product Quantity | Freq. Percent Cum. ----------------------------------------+----------------------------------- | 1 1.39 1.39 1 | 2 2.78 4.17 1 unit | 3 4.17 8.33 1,022 bottles | 1 1.39 9.72 1,331 units | 1 1.39 11.11 1,660 extraction trays | 1 1.39 12.50 10 | 3 4.17 16.67 10 units | 1 1.39 18.06 10,622 bags | 1 1.39 19.44 1039 systems | 1 1.39 20.83 10693 | 1 1.39 22.22 11,808 bags | 1 1.39 23.61 12 units | 1 1.39 25.00 122 instruments | 1 1.39 26.39 132 units total for all varieties | 3 4.17 30.56 136 boxes | 1 1.39 31.94 14317 | 1 1.39 33.33 15 instruments | 1 1.39 34.72 156 instruments | 1 1.39 36.11 16 | 1 1.39 37.50 16,380 units | 1 1.39 38.89 18,021 Bottles | 1 1.39 40.28 19009 | 1 1.39 41.67 2 | 1 1.39 43.06 2 instruments | 2 2.78 45.83 2 units | 1 1.39 47.22 2,988 bottles | 1 1.39 48.61 20 extraction trays | 1 1.39 50.00 20-40 units | 1 1.39 51.39 204 (199 US, 5 OUS). | 1 1.39 52.78 27,176 units | 1 1.39 54.17 28036 | 1 1.39 55.56 3,093 instruments | 1 1.39 56.94 36,538 bottles | 1 1.39 58.33 4 units | 1 1.39 59.72 4,966,575 Vials | 1 1.39 61.11 40,730 vials | 1 1.39 62.50 44 systems | 1 1.39 63.89 460 boxes | 1 1.39 65.28 5 | 1 1.39 66.67 50,530 bags | 1 1.39 68.06 5138 | 1 1.39 69.44 57 boxes | 1 1.39 70.83 6,041 bottles | 1 1.39 72.22 6183 | 1 1.39 73.61 6397 | 1 1.39 75.00 65 instruments | 1 1.39 76.39 651 | 1 1.39 77.78 71 instruments | 1 1.39 79.17 71945 | 1 1.39 80.56 75 devices | 1 1.39 81.94 79 | 1 1.39 83.33 83 instruments | 1 1.39 84.72 87 Products | 1 1.39 86.11 878 kits | 1 1.39 87.50 895 instruments | 1 1.39 88.89 899 units | 1 1.39 90.28 9756 | 1 1.39 91.67 9769 Total (6000 US) | 1 1.39 93.06 Domestic: 2771 units; Foreign: 7744 u.. | 2 2.78 95.83 Domestic: 339 sales units; Foreign: 1.. | 1 1.39 97.22 Lot 4112 - 2,340/8-oz jars and Lot 4.. | 1 1.39 98.61 USA: 56 units, Canada: 2 units | 1 1.39 100.00 ----------------------------------------+----------------------------------- Total | 72 100.00 Frequencies for reasonforrecall variable in enfrep20141007 dataset : Reason for Recall | Freq. Percent Cum. ----------------------------------------+----------------------------------- Ingenuity CT system can mislabel the.. | 1 1.39 1.39 Additional caution statements have be.. | 10 13.89 15.28 Blade can shift during shipping which.. | 1 1.39 16.67 Blood products, collected from a dono.. | 2 2.78 19.44 Boskovich Farms is recalling Roma Tom.. | 2 2.78 22.22 Correction due to the detection of a .. | 1 1.39 23.61 During production, excess metal (alum.. | 1 1.39 25.00 Failed Tablet/Capsule Specifications:.. | 2 2.78 27.78 GE Healthcare has become aware of a p.. | 1 1.39 29.17 Goya de Puerto Rico is recalling the .. | 10 13.89 43.06 Label does not declare wheat. | 3 4.17 47.22 Lack of Assurance of Sterility: A sma.. | 1 1.39 48.61 Lack of Assurance of Sterility: All c.. | 1 1.39 50.00 Lack of Assurance of Sterility; leaki.. | 1 1.39 51.39 Low assay result for the Pyrimethamin.. | 1 1.39 52.78 Lumenis initiated a field-correction .. | 1 1.39 54.17 Marketed Without an Approved NDA/ANDA.. | 3 4.17 58.33 One Service Technician may not have c.. | 1 1.39 59.72 Ortho Clinical Diagnostics identified.. | 1 1.39 61.11 Plateletpheresis product, lacking pro.. | 1 1.39 62.50 Presence of Foreign Tablets/Capsules;.. | 1 1.39 63.89 Presence of Particulate Matter: Confi.. | 1 1.39 65.28 Presence of Particulate Matter: Poten.. | 1 1.39 66.67 Presence of Particulate Matter: parti.. | 1 1.39 68.06 Product was distributed past its expi.. | 1 1.39 69.44 Siemens Healthcare Diagnostics has re.. | 1 1.39 70.83 Siemens Medical Solutions USA, Inc. i.. | 2 2.78 73.61 Some users of ENVOY 500 AST Reagent K.. | 1 1.39 75.00 Source plasma product, for which dono.. | 1 1.39 76.39 The Directions for Use (DFU) manual c.. | 2 2.78 79.17 The Persona 48mm X 2.5mm Female Screw.. | 1 1.39 80.56 The firm has identified an issue with.. | 2 2.78 83.33 The firm is distributing the Rejuvena.. | 1 1.39 84.72 The pediatric breathing circuits can .. | 1 1.39 86.11 The product is contaminated with Pseu.. | 1 1.39 87.50 There is a specific Extraction Tray l.. | 2 2.78 90.28 This recall has been initiated due to.. | 1 1.39 91.67 Tj's Place is recalling Basil Pesto P.. | 1 1.39 93.06 Two (2) failures of the spring link c.. | 1 1.39 94.44 Two malfunctions posing potential ris.. | 4 5.56 100.00 ----------------------------------------+----------------------------------- Total | 72 100.00 Frequencies for recallinitiationdate variable in enfrep20141007 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 17jun2013 | 2 2.78 2.78 26feb2014 | 1 1.39 4.17 04mar2014 | 1 1.39 5.56 24apr2014 | 2 2.78 8.33 05may2014 | 3 4.17 12.50 19may2014 | 4 5.56 18.06 30may2014 | 10 13.89 31.94 17jun2014 | 1 1.39 33.33 04jul2014 | 1 1.39 34.72 08jul2014 | 2 2.78 37.50 10jul2014 | 1 1.39 38.89 18jul2014 | 1 1.39 40.28 24jul2014 | 1 1.39 41.67 28jul2014 | 2 2.78 44.44 29jul2014 | 2 2.78 47.22 30jul2014 | 10 13.89 61.11 01aug2014 | 1 1.39 62.50 07aug2014 | 1 1.39 63.89 08aug2014 | 1 1.39 65.28 11aug2014 | 1 1.39 66.67 12aug2014 | 1 1.39 68.06 14aug2014 | 1 1.39 69.44 15aug2014 | 2 2.78 72.22 18aug2014 | 1 1.39 73.61 19aug2014 | 2 2.78 76.39 20aug2014 | 1 1.39 77.78 25aug2014 | 1 1.39 79.17 02sep2014 | 4 5.56 84.72 03sep2014 | 1 1.39 86.11 05sep2014 | 1 1.39 87.50 08sep2014 | 2 2.78 90.28 09sep2014 | 1 1.39 91.67 11sep2014 | 2 2.78 94.44 12sep2014 | 2 2.78 97.22 15sep2014 | 1 1.39 98.61 29sep2014 | 1 1.39 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for recallinitiationdatestr variable in enfrep20141007 dataset : Recall | Initiation | Date | Freq. Percent Cum. ------------+----------------------------------- 02/26/2014 | 1 1.39 1.39 03/04/2014 | 1 1.39 2.78 04/24/2014 | 2 2.78 5.56 05/05/2014 | 3 4.17 9.72 05/19/2014 | 4 5.56 15.28 05/30/2014 | 10 13.89 29.17 06/17/2013 | 2 2.78 31.94 06/17/2014 | 1 1.39 33.33 07/04/2014 | 1 1.39 34.72 07/08/2014 | 2 2.78 37.50 07/10/2014 | 1 1.39 38.89 07/18/2014 | 1 1.39 40.28 07/24/2014 | 1 1.39 41.67 07/28/2014 | 2 2.78 44.44 07/29/2014 | 2 2.78 47.22 07/30/2014 | 10 13.89 61.11 08/01/2014 | 1 1.39 62.50 08/07/2014 | 1 1.39 63.89 08/08/2014 | 1 1.39 65.28 08/11/2014 | 1 1.39 66.67 08/12/2014 | 1 1.39 68.06 08/14/2014 | 1 1.39 69.44 08/15/2014 | 2 2.78 72.22 08/18/2014 | 1 1.39 73.61 08/19/2014 | 2 2.78 76.39 08/20/2014 | 1 1.39 77.78 08/25/2014 | 1 1.39 79.17 09/02/2014 | 4 5.56 84.72 09/03/2014 | 1 1.39 86.11 09/05/2014 | 1 1.39 87.50 09/08/2014 | 2 2.78 90.28 09/09/2014 | 1 1.39 91.67 09/11/2014 | 2 2.78 94.44 09/12/2014 | 2 2.78 97.22 09/15/2014 | 1 1.39 98.61 09/29/2014 | 1 1.39 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for reportdate variable in enfrep20141007 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 07oct2014 | 72 100.00 100.00 ------------+----------------------------------- Total | 72 100.00 Frequencies for reportdatestr variable in enfrep20141007 dataset : Report Date | Freq. Percent Cum. ------------+----------------------------------- 10/07/2014 | 72 100.00 100.00 ------------+----------------------------------- Total | 72 100.00 by Jean Roth , jroth@nber.org , 18 Dec 2015