Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set
FDA device recall Z-1455-2014 · posted 2014-04-11 · Terminated
Recall details
- Recalling firm
- Gambro Renal Products, Incorporated
- Reason for recall
- Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
- Action taken
- On 12/9/13 and 3/12/14, a field safety notice sent via UPS overnight delivery informing customers of issue and if any customer wants to return product, a hold at distribution centers and manufacturer quarantine areas. Upon reconciliation of returned product a destruction disposition with certification.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FJK
- Quantity affected
- 306,525 sets (20435 boxes of 15 sets)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
- Date initiated
- 2013-12-09
- Date posted
- 2014-04-11
- Date terminated
- 2015-12-22
- Location
- Lakewood, CO
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