The Recall Desk
HighFDA (Devices)·Z-1895-2013·Announced 2013-08-14

TopCare Wound Closure Adhesive Surgical Tape Strips Recalled for Sterility Concerns

ASO, LLC is recalling TopCare Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is the inability to confirm sterility, which poses a risk of infection (risk-of-harm product) but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

ASO, LLC is recalling TopCare Wound Closure Adhesive Surgical Tape Strips, 30 strips 1/4 in. x 4 in., sterile latex free, UPC # 036800165854. The recall was initiated by Aspen Surgical Products, Inc. due to the inability to confirm the sterility of the product. The affected product is used to secure, close, and support small cuts and wounds.

The recall involves a total of 2,689,560 pouches (2 cards per pouch). The affected ASO Packaging Lot numbers are 121860, 141870, 145000, and 147910. The product was distributed nationwide, including in Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin.

Consumers who have purchased this product should stop using it and contact the manufacturer for further instructions or a refund. The recall is classified as Class II by the FDA, indicating that use of or exposure to the product may cause temporary or medically reversible health consequences.

The recalled product

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.
Manufacturer
ASO, LLC
Category
Medical Device — Wound Care
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • ASO Packaging Lot#s: 121860
  • 141870
  • 145000
  • and 147910

Distribution

Distributed nationwide across the United States.

The notice also names 13 states specifically:

Part of a larger recall action

This product is one of 9 recalled by ASO, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 9 products in this recall →

Related recalls

Same manufacturer · ASO, LLC

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Same hazard · sterility

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