Device product
SPS-1, Static Preservation Solution [1 or 2 liter bags], Sterile; Organ Recovery Systems, One Pierce Place, Itasca, IL 60143
Z-1111-2017
Product summary
- Event
- Event 75978
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,806 bags (3000 1 Liter bags, 1806 2-Liters bags)
- Official record key
device-enforcement:Z-1111-2017
Official wording
Reason: Organ preservation fluid recalled due to potential for bacterial contamination.
Code information: Batch / Lot Number: PBR-0060-392, Reference Number: SPS1_1 LITER, Manufacturer Date: 06/22/2016, Expiration Date: 06/22/2018 ; Batch / Lot Number: PBR-0074-330, Reference Number: SPS1_2 LITER, Manufacturer Date: 07/13/2016, Expiration Date: 07/13/2018 Batch / Lot Number: PBR-0074-337 Batch / Lot Number: PBR-0060-386
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
bacterial contamination