Surgidac Uncoated Braided Polyester sutures recalled due to sterile barrier breach
Covidien is recalling Surgidac Uncoated Braided Polyester sutures (5-0, 45cm) due to a sterile barrier breach in the breather pouch. This breach may cause infection or vision loss in ophthalmic patients undergoing direct surgical contact.
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: FDA Class II recall involving a sterile barrier breach in surgical sutures used in ophthalmic procedures. While the breach poses a theoretical risk of infection or vision loss through contamination, no reported illnesses or injuries are mentioned in the source material.
Plain-English summary
Covidien, LP is recalling Surgidac Uncoated Braided Polyester suture (Model D-1764K, 5-0, 45cm). Approximately 2,070 units are affected.
The recalled sutures have a sterile barrier breach in the breather pouch. This breach may cause infection or vision loss in patients undergoing ophthalmic procedures where there is direct patient contact with the suture.
The affected product has been distributed nationwide in the United States and to numerous countries internationally.
The recalled product
- Product
- Surgidac Uncoated Braided Polyester suture Product Description D-1764K SURGIDAC* 5-0 WHI 45CM SS24DA
- Manufacturer
- Covidien, LP
- Affected units
- 2,070
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)
- GTIN: 20884521064710
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 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.
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