Device product
(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with compression of approximately 40 mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes. (2) JOBST Compri2 lite, REF 76271-02, containing 2 components, one plastic-wrapped padding (as is contained in REF 76271-01) and one plastic wrapped compression bandage with a compression of approximately 20-30mmHg packaged into a pouch and then both components are packaged into a folding box. Shipping case contains 10 folding boxes.
Z-1228-2022
Product summary
- Firm
- BSN Medical Inc
- Event
- Event 89530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,677
- Official record key
device-enforcement:Z-1228-2022
Official wording
Reason: The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
Code information: Lot #127384, Exp. 2024-02-10 UDI for JOBST Compri2 - (01)04042809506648(20)01(17)240210(10)127384; UDI for JOBST Compri2 lite - (01)04042809506631
Distribution pattern: US Nationwide distribution in the states of AZ, FL, CA, IL, KS, MA, MN, MO, NC, NH, OH, PA, TX, VA, and WA. There was no foreign/government/military distribution.
Derived failure modes
-
Labeling or packaging
mislabeled