CLASS II Device recall · Reported 14 Aug 2013 · FDA Enforcement Report

Leader Wound Closure Adhesive Surgical Tape Strips 30 strips recalled

ASO is recalling Leader Wound Closure Adhesive Surgical Tape Strips 30 strips, distributed nationwide in the US. The recall was initiated on 26 Jul 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542

Quantity recalledTotal 2,689,560 pouches (2 cards/pouch)

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1892-2013
FDA event ID: 65819
Recalling firm: ASO, Sarasota, FL
Classification: Class II
Status: Terminated
Recall initiated: 26 Jul 2013
FDA classified: 6 Aug 2013
Reported: 14 Aug 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Surgical Instruments

Timeline

26 Jul 2013	Recall initiated by company
6 Aug 2013	Classified by FDA	+11 days
14 Aug 2013	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

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

Nationwide Florida Iowa Illinois Michigan North Carolina New York Ohio Oregon Pennsylvania Rhode Island Texas Washington Wisconsin

Questions about this recall

Is Leader Wound Closure Adhesive Surgical Tape Strips 30 strips recalled?

Yes. ASO recalled Leader Wound Closure Adhesive Surgical Tape Strips 30 strips on 26 Jul 2013. The recall is Class II and its status is Terminated. Recall number Z-1892-2013.

Why was it recalled?

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

Which lots are affected?

ASO Packaging Lot #s: 114870, 321860, 386990, 474650, 386990, 223251, 237641, 328481, 228682, and 266542

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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