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Recall Observatory FDA recall evidence

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Recalled products

The canonical enforcement rows. Everything else groups, enriches, or interprets these records.

Indexed record set

86,536 products

Page 3421 of 3462

Product Firm Event Initiated
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7J. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HVF7P. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 151HF7. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model TS057HF7. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 141F7. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131HF7P. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Churchill Medical Systems, Inc. DRESSING CHANGE KIT Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 1 Unit per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box Prefilled syringes are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Edwards Lifesciences Swan-Ganz Thermodilution VIP Catheters Model 131F7P. For use in patients who require hemodynamic monitoring. Edwards Lifesciences, LLC Event 62278 May 11, 2012
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens Vygon Corporation Event 61945 May 11, 2012
Organic Paprika packaged under the following labels: (1) Archer Farms organic Paprika, packaged in 1.0-oz rectangle glass bottles, packed in cases-9 glass bottles/case, Distributed by: Target Corporation, Minneapolis, MN 55483; and (2) O Organic organic Paprika, packaged in 1.6-oz glass bottles, packed in cases- 48 glass bottles/case, Distributed by: Lucerne Foods, Inc, Pleasanton, CA 94566. Brinkhoff & Monoson Inc Event 61844 May 11, 2012
Salted/marinated Pollock roe packaged in white plastic trays with either a clear or opaque plastic lid. Product is packaged in 1.0 lb., 2.2 lb., and 5 lb. sizes and is labeled in part: "Marinated Pollock Roe***Weight: 5.0lb***Production Date: March 2012 Packed by: Young Ocean Inc. 20233 80th Ave. S., Kent, WA 98032". There are 2 labels for the 1.0 lb. size which read in part: 1. "Salted Pollock Roe***Spicy:***Colored***Net Weight: 1.0LB (435g) Ingredients: Pollock Roe, Salt, MSG, Sorbitol, Sake, Mirin Best Before: April 2015***Young Ocean Inc.***". 2. "Salted Pollock Roe***Net Weight: 1.0 LB (435g) Ingredients: Pollock Roe, Salt, MSG, Sorbitol, Sake, Mirin, NaNo2, Artificial Color Additives (R-40, Y-5, R-5) Best Before: April 2015***Young Ocean Inc.***". Young Ocean, Inc Event 61894 May 11, 2012
Perouse Flamingo, Model 0218TA and 0218TB intended for use during cardiovascular procedure to create, maintain and monitor pressure in the balloon catheter. Perouse Medical Event 68795 May 10, 2012
Persimmon Hill Farm, Shiitake Mushroom Sauce, packaged in 8 oz/glass jars. The firm name on the label is Persimmon Hill Farm, 367 Persimmon Hill Lane, Lame, MO 65681. Persimmon Hill Farm Gourmet Foods Event 61840 May 10, 2012
The product has the Catalogue/Part number 60010. Olympic Cool-Cap System is a selective head cooling system for treatment of hypoxic-ischemic encephalopathy (HIE) in infants. A cooling water cap is placed on the infant's head and the body is warmed using radiant warmers. The Cool-Cap provides 72 hours of monitored cooling. The device is labeled in parts: "***OLYMPIC COOL-CAP Cooling Unit***Natus Medical Incorporated 5900 First Avenue South ***Made in USA***Control Unit Model No. 60010***Software in this product is***Technical Service***" Natus Medical Incorporated Event 61835 May 09, 2012
Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R) Aesculap, Inc. Event 63223 May 09, 2012
CUSTOM CPB CATHETER KIT-DR. The Sarns High Flow Aortic Arch Cannula is indicated for use in perfusion of the ascending aorta during cardiopulmonary bypass surgery. Terumo Cardiovascular Systems Corporation Event 61742 May 09, 2012
Covidien ROTICULATOR 55-4.8 Single Use Stapler REF# 017614 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis Covidien LP Event 61942 May 09, 2012
Covidien ROTICULATOR 30-V3 Single Use Stapler REF# 017619 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis Covidien LP Event 61942 May 09, 2012
Brand name: RayStation. Generic name: Treatment Planning System. Software version and build numbers are 2.5.0.144 and 2.5.1.89. Product lifetime is 5 years. RayStation is a software system designed for treatment planning and analysis of radiation therapy. The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs. The intended users of RayStation shall be clinically qualified radiation therapy staff trained in using the system. RAYSEARCH LABORATORIES AB Event 62967 May 09, 2012
Covidien ROTICULATOR 30-4.8 Single Use Stapler REF# 017617 The RETICULA TOR TM Single Use Staplers have applications in abdominal, gynecologic and pediatric surgery for resection, transection, and creation of anastomosis Covidien LP Event 61942 May 09, 2012

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