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U.S. Department of Health and Human Services

Enforcement Report - Week of August 14, 2013

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Event Detail

Event ID 65819
Product Type Devices
Status Ongoing
Recalling Firm ASO, LLC
City Sarasota
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-07-26
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Nationwide Distribution including FL, IA, IL, MI, NC, NY, OH, OR, PA, RI, TX, WA and WI.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
HEB Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 041220302536 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 143560, 171871, 250861, 379061, 402860, 418910, 513820, and 544130 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1891-2013
Duane Reade (DR) Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 639194043885 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 175770 and 209340 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1890-2013
Discount Drug Mart Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 093351120374 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #: 208351 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1889-2013
Leader Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 096295114706 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1892-2013
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. 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 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1888-2013
Walgreens ("W" and "Well at Walgreens") Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # ("W") 311917111728 item # 479241 UPC # ("Well at Walgreens") 311917143354 item # 156744 Used to secure, close and support small cuts and wounds. ASO Packaging Lot#s: 100253, 103163, 105082, 109110, 111711, 114813, 120250, 123273, 126652, 130303, 142072, 144902, 144912, 144932, 144942, 144952, 144962, 144982, 144992, 145002, 145012, 145022, 145032, 145042, 145052, 145062, 145412, 1453470, 154452, 158512, 163272, 168391, 184482, 190112, 191830, 204872, 214272, 223482, 225511, 225820, 234871, 235941, 237882, 238041, 242061, 248891, 264180, 267631, 270552, 271031, 280441, 283001, 290581, 291202, 297932, 306912, 312671, 316222, 320221, 322632, 324362, 324901, 329651, 334670, 338241, 368051, 390340, 473410, 481090, 517690, 532540, 549000, 558990, 28538, and 29020 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1896-2013
TopCare Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 036800165854 Used to secure, close and support small cuts and wounds. ASO Packaging Lot#s: 121860, 141870, 145000, and 147910 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1895-2013
Premier Value Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 040986021558 Used to secure, close and support small cuts and wounds. ASO Packaging Lot#s: 218620, 354840, 546660, 115451, 223771, 285451, 324201, 366061, 193702, 227822, 263592, 302572, 123313, 123293, 123303 123313, 123283, and 28955 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1894-2013
Meijer Wound Closure Adhesive Surgical Tape Strips 30 strips 1/4 in. x 4 in. Sterile latex free UPC # 719283595973 Used to secure, close and support small cuts and wounds. ASO Packaging Lot #s: 123120 and 324880 Class II This recall has been initiated by Aspen Surgical Products, Inc., due to the inability to confirm sterility. Total 2,689,560 pouches (2 cards/pouch) Z-1893-2013
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