Recalling Firm
Philips Electronics North America Corporation

Initial Firm Notification of Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Distribution Pattern
Worldwide Distribution: US (Nationwide) and countries of: Canada, Great Britain, Panama, Germany, India, Philippines, and Oman.
Distributed to states of: AL, FL, GA, NY, TX, and VA.
Nationwide in US; Internationally Argentina, Netherlands & Canada
Nationwide thru mail orders to include: AR, CA, FL, GA, IA, IL, KY, MD, MO, NC, NV, NY, OH, SC, TN, TX, WA
Worldwide Distribution -- US, Argentina, Canada, Chile, China, Columbia, Costa Rica, France, Georgia, Germany, Ghana, Greece, Hong Kong, India, Italy, Japan, Kazakhstan, Mexico, Morocco, Myanmar, Nepal, Philippines, Poland, Russia, Rwanda, Saudi Arabia, Slovakia, South Africa, South Korea, Thailand, Turkey, United Kingdom, and Vietnam.
Nationwide through retail and online sales.
One distributor. No govt/VA/military/foreign consignees.
DE, FL, MD, NC, SC, VA and Washington, DC.

Product Description
Euro Diagnostica DIASTAT ANA (anti-nuclear antibody) ELISA DIASTAT ANA (anti-nuclear antibody) A positive ANA test result provides presumptive evidence for systemic rheumatic disease; further definition of specific antibody profiles is a valuable aid in the diagnostic process.
Medfusion, Syringe Infusion Pump, Software Version 6 (V6), Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
Medfusion, Syringe Infusion Pump, Software Version V1.1, Rx Only, Manufactured by Smiths Medical ASD, Inc., 1500 Eureka Park, Lower Pemberton, Ashford, Kent, TN25 4BF, UK. In the administration of fluids requiring precisely controlled infusion rates including blood or blood products, lipids, drugs, antibiotics, enteral solutions and other therapeutic fluids.
Ceres Self-Drilling Variable Screw 4.0 x 12mm The Ceres screws are self-drilling variable screws that are intended to be used with the Ceres-C Stand-Alone Cervical System.
Enhanced Vegetal Vigra 200 mg Capsules, 8 count bottles, Manufacturer: Hand-shaking (Int'l) Cop. USA, ADD: Hand-shaking Mansion, the 5th Ave., Stanford, USA --- UPC# 8931028556885
Lateral Troch Plate Full Crimp - 254mm, model # 350838
Lateral Troch Plate Full Crimp - 254mm, model # 350837
CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
CER BIOLOXD OPTION HD 32MM, model # 650-1056
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
OSS CEMENTED IM STEM 12X150, model # 150366
COMP PRIMARY STEM 8MM MINI, model # 113628
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b) 1000-count bottle (NDC 59762-1061-2), Rx Only, Distributed by: Greenstone LLC. Peapack, NJ 07977
Zoloft (sertraline HCl) tablets 25 mg* 30-count bottle, Rx only, Distributed by Roerig Division of Pfizer Inc., NY, NY, 10017 NDC 0049-4960-30
Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefilled single-use syringes per carton, Rx only, Fresenius Kabi Lake Zurich, IL 60047, NDC 76045-001-20
Dark Chocolate covered Gingersnaps. Packaged as follows: 1. in clear plastic ziplock bag, sizes range from 8 oz - 12 oz., product code 038-6025-901 2. in a decorative circular gift tin, product #0368 Christmas Ginger Snap Variety
UniCel DxC 600i SYNCHRON Access Clinical Systems; A25656, A25638. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Access 2 Immunoassay System, Remanufactured, Catalog Number 386220. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
Access 2 Immunoassay System, Catalog Number 81600N. In vitro diagnostic device used for the quantitative, semi-quantitative, or qualitative determination of various analyte concentrations found in human body fluids.
CADD-Legacy(R) 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Rapunzel Vegetable Bouillon ( no added salt ), 2.4 oz. net weight, in a thick paper sleeve containing 8 foil-wrapped bouillon cubes, 12 units per case .
SPRINGFIELD SMOKED FISH Smoked Chubs, catch weight UPC: N/A
SPRINGFIELD SMOKED FISH PRESLICED Belly Lox / SPRINGFIELD SMOKED FISH ALL NATURAL BELLY (SALTY) LOX, 4oz and sliced sides, UPC: 045049113311
Boston Salads Scallion Cream Cheese Spread, 5 lbs. and Rachael's SPRINGFIELD SMOKED FISH 8 oz. and 5 lb. UPC: 045049117746
Rachael's SPRINGFIELD SMOKED FISH Smoked Trout 6 oz, UPC: 045049117258
SPRINGFIELD SMOKED FISH HOT AND SPICY CREAM CHEESE SPREAD, 8 oz. and 5 lb. UPC: 045049117920
SPRINGFIELD SMOKED FISH Whitefish Salad. 8 oz UPC: 045049117425 5 lb UPC: 045049117425
RACHAEL'S SPRINGFIELD SMOKED FISH PASTRAMI LOX, 4 oz. sliced sides, UPC: N/A
springfield smoked fish whole unsliced nova side, catch weight, UPC: N/A; - SPRINGFIELD SMOKED FISH nova salmon chips, 5 lb.; SPRINGFIELD SMOKED FISH SLICED SMOKED NOVA CHIPS, 1 lb., UPC: 045049113212 and 5 lb., UPC: N/A; Rachael s SPRINGFIELD SMOKED FISH SMOKED NOVA SALMON BITS, 8 oz., UPC: 045049112079 - SPRINGFIELD SMOKED FISH SMOKED SALMON WINGS AND BELLIES, NET WT. 5 lb., UPC: 045049111256 - SPRINGFIELD SMOKED FISH SPREADABLE SMOKED NOVA SALMON, 8 oz., UPC: 045049113236; 1.25 lb. UPC: 045049112413; 5 lb. UPC: 045049112406 - SLICED SMOKED NOVA SALMON BAGEL CUTS, 1 lb., UPC: 045049112086
Rachael's SPRINGFIELD SMOKED FISH SPREADABLE CREAM CHEESE SPREAD, 8oz. and 5 lb. UPC: 045049117708
SPRINGFIELD SMOKED Whitefish Meat, 5 lb bag, UPC: 045049117111
Rachael's SPRINGFIELD SMOKED FISH LOX CREAM CHEESE SPREAD, 8 oz. and 5 lb. UPC: 045049117760
Boston Salads Veggie Cream Cheese Spread, 5 lbs. UPC: 611140151714 and Rachael's SPRINGFIELD SMOKED FISH VEGGIE CREAM CHEESE SPREAD, 8 oz. and 5 lb. UPC: 045049117739
Traditional Kippered Salmon, catch weights, UPC: 045049117012
Rachael's SPRINGFIELD SMOKED FISH STRAWBERRY CREAM CHEESE SPREAD, 8 oz. and 5 lb. UPC: 045049117784
SPRINGFIELD SMOKED FISH Smoked Sable, Catch weight, UPC: N/A
SPRINGFIELD SMOKED FISH Hot Smoked Salmon Steaks, catch weights, UPC: N/A
SPRINGFIELD SMOKED FISH Smoked Whole Whitefish, catch weight, UPC: N/A
SPRINGFIELD SMOKED FISH CHUNKY WHITEFISH SPREAD 8 oz., UPC: 045049117432 and 4 lb. UPC: 045049117418
SPRINGFIELD SMOKED FISH Smoked Bluefish, catch weight UPC: 045049117357
Meijer Fresh Cranberry Apple Stuffing Starter 18.9 Oz retail unit in plastic container UPC: 7-19283-37977-1 4 retail containers per wholesale case
Meijer Sharable Waldorf Salad 16 Oz retail unit in plastic container UPC: 7-13733-53864-0 4 retail containers per wholesale case
Meijer Michigan Harvest Salad 10 Oz retail unit in plastic container UPC: 7-08820-68400-3 4 retail containers per wholesale case
Buttermilk Herb Side Salad, prepacked in a clear plastic container, sold by the unit for $2.99, UPC 252326-602998.
SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
Red Button Vintage Creamery, Caramel Cashew Ice Cream, 56 fluid ounce. UPC 077865010109. Case Pack UPC # 077865010109 AFS Item Number 6470413. Packaged in Paper Tubs.
Harris Teeter's HT Traders Mama Biscotti Mini Biscotti, Triple Chocolate, UPC: 7203670827.
Early Dawn; Whole Tilapia IQF, Gutted & Scaled, Farm Raised, 40 lbs.; Size 550-750g OR 750g+, Lot No.: 1985507; Production Date: 08/12/2017; Best Used By Date: 02/12/2019; Product of China.
Mobile Detector Holder - Stationary X-ray System (RF System). suitable for positioning the wireless portable detector free in the room for X-ray exposures. It supports the wireless portable detector with or without a grid.

Product Quantity
43606.61 pounds (total for all products)

Reason for Recall
Euro Diagnostica has identified a deviation in one of the components of the DIASTAT ANA (FANA200), lot TS 2076. The kit might not perform correctly and so potentially yield false positive samples.
Incorrect direct marking and color identification for the affected lot of Ceres Self-Drilling Variable Screws. Although the laser mark and color identify the screws as 12 mm in length, some screws in the lot measure 14 mm in length.
Marketed without an Approved NDA/ANDA; FDA analysis found product to be tainted with Sildenafil.
Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Labeling: Label MIX-UP. Blister Packages, Labeled as Midazolam injection, USP, 2 mg / 2 ml, Containing Syringes of Ondansetron Injection, USP, 4 mg / 2 mL
Figi's is recalling Gift #0368 Christmas Gingersnap Variety and Bulk Dark Chocolate Gingersnaps due to undeclared milk.
Potential for minor skin burn if the tool contacts the reagent storage interface board (B79917) when performing a pipettor alignment.
Blood products, which may have been exposed to unacceptable temperature during storage/transit, were distributed.
Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed.
The front of the product label says no added salt, but sea salt is correctly listed in the ingredient statement on the back.
Product may be contaminated with Listeria monocytogenes.
Product tested positive for Listeria monocytogenes.
Device was distributed with the etching missing from the product.
Sliced apples within the products being potentially contaminated with Listeria monocytogenes.
Undeclared wheat in the croutons. Buttermilk Herb Side Salad contains the crouton but the label does not declare wheat.
Centurion is recalling specific lots of convenience kits, SafetyGlide Needle, 22GA 1-1/2in, manufactured by BD, sold in Centurion Convenience Kits. distributed between May 2016 and June 2017 due to notice received from BD's recall due to particulate that could be expelled out of the needle if used for injection.
Casper's Ice Cream is recalling Caramel Cashew Ice Cream due to undeclared almonds.
Early Dawn Whole Tilapia was sampled and found positive for the antibiotic, Sulfadiazine.
If the lock mechanism of the movable camp of the mobile detector holder is not adjusted properly or not secured, the portable detector can drop down when the moveable clamp is at the bottom (below of the detector) and additional force is applied. This may happen when the detector is rotated clockwise from landscape to portrait position.

Code Info
Lot/Unit Numbers: Use by 12/15/17 through 2/9/18
printed labels include sell by range of December 17, 2017 through December 21, 2017
Packed on Dec 18, 17 Sell by Dec 23, 17. Packed on Dec 19, 17 Sell by Dec 24, 17.
Lot No.: 1985507; Production Date: 08/12/2017; Best Used By Date: 02/12/2019
9890-010-88152 - Codes included in attached list. Devices were manufactured and distributed from March 2015 - March 2017.