FDA Enforcement Class II Terminated

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.

Recall: Z-1888-2013 · Reported August 14, 2013

Enforcement

Recall Number
Z-1888-2013
Event ID
65819
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
ASO, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
August 14, 2013
Initiation Date
July 26, 2013
Classification Date
August 6, 2013
Termination Date
August 4, 2014
Address
300 Sarasota Center Blvd, N/A, Sarasota, FL, 34240-9381, United States

Description

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.

Reason

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

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

Distribution

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

Quantity

Total 2,689,560 pouches (2 cards/pouch)