RecallDepth

CVS Pharmacy Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 050428102909 item # 409170 Used to secure, close and support small cuts and wounds.

This recall has been terminated (originally issued August 6, 2013).

Company
Aso, Llc
Recall Initiated
July 26, 2013
Posted
August 6, 2013
Terminated
August 4, 2014
Recall Number
Z-1888-2013
Quantity
Total 2,689,560 pouches (2 cards/pouch)
Firm Location
Sarasota, FL
Official Source
View on FDA website ↗

Reason for Recall

This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility.

Distribution

Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.

Lot / Code Info

ASO Packaging Lot #s: 101173, 102040, 1020631, 111450, 112092, 112102, 112623, 114833, 114843, 114853, 114863, 114873, 114883, 114843, 114853, 114863, 114873, 114883, 120343, 123542, 124890, 126582, 130313, 130973, 136592, 141962, 145172, 149421, 149742, 149752, 149762, 149772, 149992, 154192, 158761, 165422, 169961, 170232, 172572, 177182, 180302, 183821, 193150, 193542, 198062, 204742,207610, 228372, 231481, 233652, 234272, 238871, 245421, 259031, 265030, 310081, 312060, 318012, 318311, 324352, 324631, 335661, 345082, 363801.833711, 384420, 407470, 437940, 471090, 511940, 525910, 545400, 552850, 28781, 28982, 29040, and 29041

Root Cause

Package design/selection

Action Taken

ASO sent a letter on July 26, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately examine your inventory and stop using/distributing the product. Place in quarantine to be returned or destroyed. ASO customers will receive credit for returned product or a returned completed Certificate of Destruction. Please use Return Authorization Number 1675 when returning the product. Please complete and return the enclosed response form as soon as possible. Return the form to: Address: ASO LLC Regulatory Affairs 300 Sarasota Center Blvd. Sarasota, FL 34240 Fax: 941-378-9040 Attn: Regulatory Affairs For questions regarding this recall call 888-364-7004, ext 146.

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