Recall Z-1228-2022— BSN Medical Inc
Class II · Terminated
Class II FDA medical device recall by BSN Medical Inc, initiated 2022-02-01, terminated 2023-08-09. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- BSN Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-02-01
- Terminated
- 2023-08-09
- Firm location
- Charlotte, NC, United States
Product description
(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 for recall
The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled.
Data sourced from openFDA. This site is unofficial and independent of the FDA.