Recall Z-2266-2014 ยท DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Vascutek, Ltd.
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
| Date | Aug 18, 2014 (initiated Jul 15, 2014) |
| Status | Terminated |
| Reason | The cautery that is provided with the Gelweave graft in the box has a shorter shelf life indicated on its label, versus that of the graft (4 years and 5 years, respectively). |
| Root cause | Incorrect or no expiration date |
| Action | Vascutek sent an Urgent Field Safety Notice dated July 15, 2014, to all affect customers. The letter identified the product the problem and the action needed to be taken by the customer. User Instructions: A. Vascutek advises that you ensure suitable equipment is available prior to implantation to trim the graft if required. B. For product received with a cautery in the interim, Vascutek request that you check the shelf life of each product before every operation. If you find that the cautery is out of date, remove and discard the cautery. If you require an appropriate cautery suppli |
| Quantity | 63,162 |
| Distribution | Nationwide Distribution including the states of : AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI and WV. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.