FDA Device recall Z-1228-2022
(1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with comp…
- FDA Device
- Class II
- terminated
- Published 2022-06-15
On 2022-06-15 the FDA classified a Class II recall of (1) JOBST Compri2, REF 76271-01, containing 2 components, one plastic-wrapped padding and one plastic-wrapped compression bandage with comp… by Bsn Medical, citing the folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1228-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-02-01 |
| Published | 2022-06-15 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Bsn Medical |
| Distribution | US |
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.
Reason
The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
Identifiers
| code_info | 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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1228-2022%22
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