Device product
Terumo Glidesheath (tm), 6 French, Nitinol wire, product code 15-1060. Used to facilitate placing a catheter through the skin into a vein or artery.
Z-1612-2013
Product summary
- Event
- Event 65397
- Status
- Terminated
- Classification
- Class II
- Quantity
- 550 units
- Official record key
device-enforcement:Z-1612-2013
Official wording
Reason: Medical devices were incorrectly labeled with extended expiration dates.
Code information: Lot MP08
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Labeling or packaging
incorrectly labeled