Recall Z-1228-2022 ยท FQM Bandage, Elastic
BSN Medical Inc
(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 contain
| Date | Feb 1, 2022 |
| Status | Terminated |
| Reason | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled. |
| Root cause | Under Investigation by firm |
| Action | The recalling firm issued letters dated 1/31/2022 on 2/1/2022 via email and made telephone calls. The letter informed the consignee of the issue, provided photographs of the labeling, and requested the consignee check their inventory to determine if they have the affected lot number of JOBST Compri2 and JOBST Compri2 Lite in their inventory. If they do, they are requested to quarantine the product and share this information with additional departments as needed. Enclosed with the letter was a Response Form for completion, as well as prepared labels for return of the affected product. The |
| Quantity | 1,677 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.