Recall record at a glance
| Official record | Z-1455-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Gambro Renal Products, Inc. |
| Report date | Apr 23, 2014 |
| Recall initiation date | Dec 9, 2013 |
| Quantity | 306,525 sets (20435 boxes of 15 sets) |
| Location | Lakewood, CO, United States |
Official product description
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.
Why the product was recalled
Occluded heparin tubing events preventing anticoagulation dosing on the Gambro Cartridge Blood Sets.
Distribution information
Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, and Colombia.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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