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Recall Observatory FDA recall evidence

Device product

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.

Z-1892-2013

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-1892-2013

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: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542

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.