Device product
DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10
Z-0927-2023
Product summary
- Event
- Event 91331
- Status
- Terminated
- Classification
- Class II
- Quantity
- 157 packs
- Official record key
device-enforcement:Z-0927-2023
Official wording
Reason: DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the non-absorbable sutures that may cause a gap or wrinkle in the breather seal resulting in a sterile barrier breach.
Code information: a) REF 89-9004.09, GTIN 00749756903936, Lot Numbers: 57391129 exp 5/1/2023, 57755421 exp 5/1/2023, 57900931 exp 5/1/2023 b) REF 89-9004.10, GTIN 00749756903931, Lot Numbers: 57913767 exp 5/1/2023
Distribution pattern: US Nationwide distribution in the states of IL, MO.
Derived failure modes
-
Manufacturing or process control
manufacturing error
-
Sterility assurance
sterile barrier breach