Surgical Product Recalled Due to Torn Pouches Compromising Sterile Barrier
Ethicon Sarl is recalling SURGICEL FIBRILLAR product due to torn foil pouches that compromised the sterile barrier. Approximately 39,010 units distributed in the US, India, and Japan are affected.
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: FDA Class II recall involving compromised sterile barrier on a medical device. Although no injuries or illnesses have been reported, a compromised sterile barrier presents a risk of contamination on a product intended to remain sterile, meeting the criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Ethicon Sarl, a Johnson & Johnson Company, is recalling SURGICEL FIBRILLAR 1IN×2IN (Product Number 1963). Approximately 39,010 units were distributed in the United States, India, and Japan.
The recall was initiated because some foil pouches were found torn open during production, compromising the sterile barrier of the product. The defect was traced to a specific machine used during product packaging.
Healthcare providers and facilities with this product should stop using it immediately and return all units to Ethicon Sarl or their supplier. Patients who received this product should consult their healthcare provider if they develop any signs of infection or other health concerns.
The recalled product
- Product
- SURGICEL FIBRILLAR 1INX2IN(2.5CMX5.1CM), Product Number: 1963
- Manufacturer
- Ethicon Sarl, a Johnson & Johnson Company
- Category
- Medical Device — Surgical
- Hazard
- sterile-barrier-compromise
- contamination-risk
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)
- Product Number: 1963
- UDI/DI: 10705031003132 (primary)
- 20705031003139 (box of 10)
- Lot numbers:
Distribution
Distributed nationwide across the United States.
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