Recall Z-1517-2022 ยท FQM Bandage, Elastic
ASO LLC
(1) CVS Health Sterile Surgical Pads, Cushion Comfort, packaged 12 pads 5 in. x 9 in. per box, ASO Item No. 781083, SKU 894111 (2) CVS Health 30 Piece Wound Care Kit, For Large Size Wounds, ASO Item No. 781240, SKU 998842; and (3) equate First Aid Kit, 120 Items, containing 1 generic Sterile Trauma Pad 5 in. x 9 in., ASO Item No. 192636, SKU #30174479.
| Date | Jun 22, 2022 |
| Status | Open, Classified |
| Reason | The product falls apart during handling after removal from its primary packaging. |
| Root cause | Process control |
| Action | The recalling firm initiated the recall via email on 6/22/2022 to return the product. |
| Quantity | 274,458 retail packages |
| Distribution | Worldwide distribution - US Nationwide distribution in the states of AL, CA, FL, IN, MI, MO, NJ, NY, PA, RI SC, TN, TX, and VA. The country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.