The Recall Desk
HighFDA (Devices)·Z-1177-2023·Announced 2023-03-08

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.

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 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
Category
Medical Device — Surgical Suture / Ophthalmic
Hazard
  • sterile-barrier-breach
  • infection-risk
  • vision-loss

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.

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