BSN Medical Inc Recall 89530
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.
BSN Medical Inc Recall 89530 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1228-2022 |
| Event ID | 89530 |
| Event 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. |
| Product Type | Devices |
| 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. |
| Quantity | 1,677 |
| Recall Reason | The folding boxes within the shipping case are mislabeled. The shipping case and immediate packages within the folding boxes are correctly labeled. |
| Device Classification | 20220615 |
| Device 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 |
| Center Classification Date | 20220603 |
| Recall Initiation Date | 20220201 |
| Recalling Firm | BSN Medical Inc |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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