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Recall Observatory FDA recall evidence

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

January 12, 2017

Class II

Product summary

Firm
Vascular Solutions, Inc.
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

    reason.no_named_rule · v1.0.0

    Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.