Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Reported: August 27, 2014 Initiated: July 15, 2014 #Z-2266-2014
Product Description
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Reason for Recall
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).
Details
- Recalling Firm
- Vascutek, Ltd.
- Units Affected
- 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.
- Location
- Inchinnan
Frequently Asked Questions
What product was recalled? ▼
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company. Recalled by Vascutek, Ltd.. Units affected: 63,162.
Why was this product recalled? ▼
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).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 27, 2014. Severity: Moderate. Recall number: Z-2266-2014.
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