Recall Z-1517-2022— ASO LLC
Class II · Ongoing
Class II FDA medical device recall by ASO LLC, initiated 2022-06-22. FDA's recall record names no specific 510(k) clearance for this event. Product: (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.. Reason: The product falls apart during handling after removal from its primary packaging..
- Recalling firm
- ASO LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-06-22
- Firm location
- Sarasota, FL, United States
Product description
(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.
Reason for recall
The product falls apart during handling after removal from its primary packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.