FDA recall Z-1517-2022

ASO LLC · Class II · device

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 for recall

The product falls apart during handling after removal from its primary packaging.

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.

Key facts

Status
Ongoing
Initiation date
2022-06-22
Report date
2022-08-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sarasota, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1517-2022