| Class 2 Device Recall GrebSet MicroIntroducer Kit | |
Date Initiated by Firm | January 12, 2017 |
Create Date | February 23, 2017 |
Recall Status1 |
Terminated 3 on April 18, 2018 |
Recall Number | Z-1250-2017 |
Recall Event ID |
76363 |
510(K)Number | K081846 |
Product Classification |
Catheter, intravascular, diagnostic - Product Code DQO
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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. |
Code Information |
Lot Numbers: 581212, 584392, 594115, 597202 |
Recalling Firm/ Manufacturer |
Vascular Solutions, Inc. 6464 Sycamore Ct N Maple Grove MN 55369-6032
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For Additional Information Contact | VSIs Customer Service Dept. 763-656-4300 |
Manufacturer Reason for Recall | Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date. |
FDA Determined Cause 2 | Error in labeling |
Action | Consignees were sent on 1/12/2017 a Vascular Solutions "Urgent Medical Device Recall" letter dated January 11th, 2017. The letter identified the problem and product involved in the recall. The letter provided "Your Immediate Action Is Required". This included to remove the product from inventory and to complete and return the VSI's Account Inventory Form to VSIs Customer Service Dept. |
Quantity in Commerce | 633 |
Distribution | 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. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = DQO
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