Unsterile Plain Gut Absorbable Sutures Recalled Due to Sterilization Defect
Covidien recalled 3,228 units of Plain Gut Absorbable Sutures due to a sterilization defect. Unsterile sutures may cause infection or vision loss in eye surgery.
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: Class II medical device recall with a sterilization defect creating infection and vision-loss risks. No illnesses or injuries have been reported; the harm is theoretical. Score is 3 per rubric criterion: risk-of-harm product where injury has not yet been reported.
Plain-English summary
Covidien, LP is recalling 3,228 units of Plain Gut Absorbable Sutures (PLAIN GUT 5/0 18 P-13 X12 model SG-5686 and PLAIN GUT 4-0 18 UD SC-11 DA model SG828-2).
A calibration issue at a contract sterilization supplier may have left affected sutures unsterile. Use of unsterile sutures poses a risk of infection, or vision loss if used in ophthalmologic procedures.
The recalled sutures were distributed worldwide to the United States, Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand. Affected lot numbers are D2G1825FZY, D2H0754FZY, and D2E2595ZY.
Healthcare facilities and surgical centers should immediately verify their inventory against the affected lot numbers and discontinue use of any matched products. Patients who have undergone surgery with affected sutures should contact their healthcare provider.
The recalled product
- Product
- Plain Gut Absorbable Sutures, PLAIN GUT 5/0 18 P-13 X12 (SG-5686), PLAIN GUT 4-0 18 UD SC-11 DA (SG828-2)
- Manufacturer
- Covidien, LP
- Affected units
- 3,228
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 (5)
- GTIN: 20884521055756
- 20884521750118
- Lot: D2G1825FZY
- D2H0754FZY
- D2E2595ZY
Distribution
Part of a larger recall action
This product is one of 4 recalled by Covidien, LP 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.
See all 4 products in this recall →Related recalls
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