Z-1389-2023 Class II Ongoing
FDA device recall Z-1389-2023 was initiated by Covidien, LP on March 1, 2023 and is designated Class II. 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, … The recall status is ongoing. Affected quantity: 960 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 19, 2023
- Initiation Date
- March 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 960 units
Product Description
Mild Chromic Gut Absorbable Sutures, CH GUT 5-0 12 UD SS-14 SS-14 (G-1766-K), CHROMIC GUT 6-0 45CM HE-1 X12 (G-1780K)
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 Pattern
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.
Code Information
GTIN: 20884521054339, 20884521054438; Lot: D2H0095ZY, D2H0096ZY