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Recall Observatory FDA recall evidence

Device product

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.

Z-1895-2013

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-1895-2013

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: 121860, 141870, 145000, and 147910

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.