Reported Mar 9, 2016 · Terminated
Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an…
Medtronic Perfusion Systems
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
- Medtronic Custom Perfusion Tubing Pack, Rx, Sterile EO. Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack. This product is indicated for use in the extracorporeal circuit during cardiopulmonary bypass procedures
- Lot codes and dates
378 of 378 products
Products covered by this recall Model / number Barcodes Product as published 20985749200643169624436BB8B09R4 21003126000643169624436BB8B09R4 21025852200643169624436BB8S23R 20968575300643169624849BB8S23R 20968575400643169624849BB8S23R 21014100600643169624849HY1W12R28 20982118900643169620155M273205G 21013506500643169651258M311110F 21000756020643169409662M311110F 21030533420643169409662M311110F 21064632620643169409662M311129K 21021621500643169399280M311129K 21063762800643169399280M311135D 21038628500643169478183M311136L 21010043600643169515598M311136L 21043359900643169515598M311151D 20990321800643169475311M321304B 21016592720643169460694M321709C 21012924120643169636716M322225D 21007563600643169510203M322225D - Amount recalled
- 9890 (7773 US, 2117 OUS)
Where it was sold
Why it was recalled
Medtronic is notifying customers who have or may receive specific lots of Medtronic Perfusion Tubing Packs that include the potentially affected cuvettes manufactured by Terumo Cardiovascular Systems (Terumo CVS). Terumo Cardiovascular Systems (Terumo CVS) has distributed an Urgent Safety Alert regarding the CD I¿ H/S Cuvette. The cuvette is packaged into Medtronic Perfusion Tubing Packs and only sold as part of the pack.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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