Surgipro Sutures Recalled for Potential Sterile Barrier Perforation
FDA is recalling Surgipro sutures due to potential sterile barrier defects that could cause biocontamination and 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 involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, fitting the High severity criteria for potential infection or loss of vision.
Plain-English summary
The U.S. Food and Drug Administration (FDA) is recalling Surgipro SP-623 sutures manufactured by Covidien, LP. The recall is due to a potential perforation or tear in the sterile barrier packaging. This defect may result in biocontamination of the sterile sutures.
The product is distributed in the United States and numerous international countries. The specific lot number is D6A2963Y, and the UDI-DI is 20884521037073. A total of 135,875 units are affected.
If the sterile barrier is compromised, the sutures may become contaminated, which could lead to infection. In ophthalmic utilization, there is a risk of loss of vision. The issue may also result in prolonged surgery. Healthcare providers should check their inventory for this specific lot and discontinue use if the packaging is compromised.
The recalled product
- Product
- Surgipro SP-623 SURGIPRO* 2-0 BLU 75CM SC2 X36 SP-623
- Manufacturer
- Covidien, LP
- Category
- Medical Device — Sutures
- Affected units
- 135,875
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)
- SP-623 UDI-DI 20884521037073 Lot D6A2963Y
Distribution
Distributed nationwide across the United States.
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