Polysorb Suture Recalled for Potential Propylene Glycol Contamination
Covidien LLC is recalling Polysorb Braided Absorbable Sutures due to potential propylene glycol contamination. The recall affects 972 units distributed in California, New York, and Texas.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving potential contamination that could lead to adverse health consequences.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955, manufactured by Covidien LLC. The recall is being conducted due to potential propylene glycol contamination in the product.
The recall involves 972 units of the suture, identified by UDI 10884521043718 /20884521043715 and Lot Number A8C0783X. These products were distributed to facilities in California, New York, and Texas.
Healthcare facilities and consumers who have this specific product should stop using it immediately and contact the manufacturer or their supplier for instructions on return or disposal. The FDA classifies this as a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Polysorb Braided Absorbable Suture 1 36" 90 cm Undyed GS-21, Product Number CL-955
- Manufacturer
- Covidien LLC
- Category
- Medical Device — Sutures
- Affected units
- 972
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 (1)
- UDI - 10884521043718 /20884521043715 Lot Number - A8C0783X
Distribution
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