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Recall Observatory FDA recall evidence

Device product

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.

Z-1888-2013

July 26, 2013

Class II

Product summary

Firm
ASO, LLC
Event
Event 65819
Status
Terminated
Classification
Class II
Quantity
Total 2,689,560 pouches (2 cards/pouch)
Official record key
device-enforcement:Z-1888-2013

Official wording

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

Code information: 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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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