Reported Apr 23, 2014 · Terminated
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge…
Gambro Renal Products, Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Gambro Renal Products, Incorporated · 14143 Denver West Pkwy · Lakewood, CO · 80401-3266
Is this the product you have?
- Gambro Cartridge Blood Set, blood transport system for hemodialysis
- Model Number(s)101025 (003410510) - Cartridge set, STND PRM LN and 103401 (003414500) - Cartridge set, PRM_LN_INJ_PT. The Gambro Cartridge Sets are single use sterile tubing sets intended to provide extracorporeal blood transport circuit for hemodialysis treatments for Gambro Phoenix and COBE Centrisystem 3 (and 3+) Dialysis Delivery Systems
- Lot codes and dates
- Lot number
1000039228100004834010000506441000050648100005403210000585161000064913100006581710000658231000066430100006334710000679841000068071100007141710000714301000073434100007343610000734381000074660100007466110000746621000075553
- Lot number
- Amount recalled
- 306,525 sets (20435 boxes of 15 sets)
Where it was sold
- Nationwide
Why it was recalled
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
This product could cause temporary or reversible health problems — stop using it.
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