Device product
Sutures. MAXON: MAXON 4/0 5X18" GREEN CV-24 D-TACH; Item Number: 8886621933; MAXON 5/0 5X18 GR CV-23 D-TACH; Item Number: XX2109; MAXON* 4/0 5X30 GREEN V-20 D*TACH; Item Number: 8886603433
Z-2542-2017
Product summary
- Firm
- Medtronic
- Event
- Event 77144
- Status
- Terminated
- Classification
- Class II
- Quantity
- 478,465 (total for all products)
- Official record key
device-enforcement:Z-2542-2017
Official wording
Reason: Potential for an incomplete seal on the inner package, which may result in premature degradation of the suture material.
Code information: MAXON 4/0 5X18" GREEN CV-24 D-TACH D4K0396X D4K2053X D4L0541X D4L1084X D4L1272X D4M0394X MAXON 5/0 5X18 GR CV-23 D-TACH D4K1485X MAXON* 4/0 5X30 GREEN V-20 D*TACH D4L1156GX
Distribution pattern: Worldwide distribution. US Nationwide including PR, and countries of AU, BE, CA, CL, CN, IL, IT, JP, KR, MX, PA, SA, SG, and TR.
Derived failure modes
-
Labeling or packaging
incomplete seal