Covidien, LP: 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)

Hazard

Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk.

Details from the source

Reason for recall: Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of sutures used in the eye, pose a loss of vision risk. Distribution: Worldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA, NC, NY, OH, WA; and countries of: Canada, Colombia, El Salvador, Indonesia, Nepal, Puerto Rico, Taiwan, and Thailand. Quantity: 3228 units Lot/code info: GTIN: 20884521055756, 20884521750118; Lot: D2G1825FZY, D2H0754FZY, D2E2595ZY

UPC codes

20884521055756, 20884521750118

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.