Aspen Surgical Recalls Wound Closures Due to Sterility Concerns
Aspen Surgical Products is recalling reinforced wound closure strips because FDA sampling indicated the product may not be sterile, posing a risk of infection.
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 is classified as FDA Class II, and the hazard involves a risk of infection from non-sterile medical devices. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).
Plain-English summary
Aspen Surgical Products, Inc. is recalling reinforced wound closure strips, including Product Numbers 40-2894, 39-0058, and 40-2893. The recall was initiated because the firm could not confirm the sterility of the products after FDA sampling indicated they may not be sterile. The affected products are intended for skin closure and closure support for sutures and staples.
The use of these non-sterile wound closures could lead to infection, which may require further treatment including the use of antibiotics. As of July 18, 2013, there have been no reports of injuries or illnesses associated with the use of these products.
The recall involves 3,286 boxes (6,353,000 units) distributed in the United States (specifically Florida) and internationally in the Netherlands and Reditch Worcestershire, England. Consumers and healthcare providers should stop using the affected products and contact Aspen Surgical Products for instructions on return or replacement.
The recalled product
- Product
- Distributed in USA: Product Number: 40-2894: Reinforced Wound Closure, Latex Free Sterile EO Rx, 1/4" X 4 ", 6 mm X100 mm, (2 Cards/pouch, 1,000 Pouches/box); Distributed in Europe: " Product Number: 39-0058: Medicare Reinforced Wound Closure Strips 1/4" X 4 ", Sterile…
- Manufacturer
- Aspen Surgical Products, Inc.
- Category
- Medical Device — Wound Closure
Distribution
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