ASO Recalls HEB Wound Closure Adhesive Surgical Tape Strips Due to Sterility Concerns
ASO, LLC is recalling HEB Wound Closure Adhesive Surgical Tape Strips because the manufacturer cannot confirm the product's sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 involves a sterile medical device where sterility cannot be confirmed, creating a risk of infection (risk-of-harm product) without reported injuries, which aligns with the 'High' severity criteria.
Plain-English summary
ASO, LLC is recalling HEB Wound Closure Adhesive Surgical Tape Strips (30 strips, 1/4 in. x 4 in., sterile, latex-free) due to the inability to confirm sterility. The recalled product is used to secure, close, and support small cuts and wounds. The recall was initiated by Aspen Surgical Products, Inc.
A total of 2,689,560 pouches (2 cards per pouch) are affected. The products were distributed nationwide, including in Florida, Iowa, Illinois, Michigan, North Carolina, New York, Ohio, Oregon, Pennsylvania, Rhode Island, Texas, Washington, and Wisconsin. The affected ASO Packaging Lot numbers are 143560, 171871, 250861, 379061, 402860, 418910, 513820, and 544130.
Consumers should check their records for these specific lot numbers and stop using the product if it matches the recalled description.
The recalled product
- Product
- 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.
- Manufacturer
- ASO, LLC
- Category
- Medical Device — Wound Care
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 (8)
- ASO Packaging Lot #s: 143560
- 171871
- 250861
- 379061
- 402860
- 418910
- 513820
- and 544130
Distribution
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.
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