Agency classClass IIOur severity:High FDA (Devices)·Z-1181-2023·Announced 2023-03-08

Ti-Cron Surgical Sutures Recalled Due to Sterile Barrier Breach

Covidien is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. The defect could allow bacterial contamination, posing a risk of infection or vision loss during ophthalmic procedures.

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 of a risk-of-harm medical device where no illnesses or injuries have been reported. The sterile barrier breach poses potential for serious harm (infection, vision loss in ophthalmic procedures), meeting the threshold for High severity, but without reported cases the score remains at 3 rather than 4.

Plain-English summary

Covidien, LP is recalling Ti-Cron Coated Braided Polyester Sutures due to a sterile barrier breach in the breather pouch. This defect may compromise the sterility of the sutures, potentially allowing bacterial contamination.

The affected sutures pose a risk of infection or vision loss during ophthalmic procedures where there is direct patient contact. Approximately 40,152 units have been distributed in the United States and internationally across multiple countries. The recall affects multiple gauges and lengths of the product, with specific lot numbers identified by Covidien.

No illnesses or injuries have been reported in connection with this defect.

The recalled product

Product: Ti-Cron Coated Braided Polyester Suture Product Description 88862775-31 TICRON* 4-0 BLU 75CM CV327DA 88862880-41 TICRON* 3-0 WHI 75CM Y31DA 88863012-61 TICRON* 0 BLU 90CM C16 X36 88863015-61 TICRON* 0 BLU 120CM V20X36 88863017-51 TICRON* 2-0 BLU 120CM SKX36 88863026-71…
Manufacturer: Covidien, LP
Category: Medical Device — Surgical Sutures
Hazard: sterile-barrier-breach
infection
vision-loss
Affected units: 40,152

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 (20)

GTIN: 20884521062303
20884521059570
20884521060101
20884521059006
20884521059396
20884521060682
20884521059013
10884521059290
20884521059297
20884521059280
10884521061194
20884521061191
20884521062327
20884521059204
20884521060637
20884521105192
20884521062921
10884521058620
20884521058627
20884521060170

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.

See all 11 products in this recall →

Same manufacturer · Covidien, LP

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Same hazard · sterile barrier breach