Gambro Cartridge Blood Set recall
Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401…
Why was Gambro Cartridge Blood Set recalled?
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot number: 1000039228, 1000048340, 1000050644, 1000050648, 1000054032, 1000058516, 1000064913, 1000065817, 1000065823, 1000066430, 1000063347, 1000067984, 1000068071, 1000071417, 1000071430, 1000073434, 1000073436, 1000073438, 1000074660, 1000074661, 1000074662, 1000075553
- Product
- Gambro Cartridge Blood Set, blood transport system for hemodialysis, Model Number(s): 101025 (003410510) - Cartridge set, STND PRM LN and 103401…
- Recalling firm
- Gambro Renal Products, Incorporated
- Quantity
- 306,525 sets (20435 boxes of 15 sets)
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
- Recall date
- April 23, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)