Device product
GrebSet Micro-Introducer Kit, model 7941, Sterilized with Ethylene Oxide. Product Usage: The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.
Z-1250-2017
Product summary
- Event
- Event 76363
- Status
- Terminated
- Classification
- Class II
- Quantity
- 633
- Official record key
device-enforcement:Z-1250-2017
Official wording
Reason: Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.
Code information: Lot Numbers: 581212, 584392, 594115, 597202
Distribution pattern: US Nationwide Distribution in the states of NH, ME, VT, NY, LA, MS, AL CA, IA, WA, OR, MD, DE, PA, NJ, ID, TX, OK, MO, WI, GA, FL, AR, OH, AZ.
Derived failure modes
-
Unknown
Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.