Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Class I - DangerousWhat Should You Do?
- Check if you have this product: 731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Vascutek, Ltd.
- 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).
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full Description:
Gelweave (TM) Vascular Prostheses Manufactured by - VASCUTEK Ltd a TERUMO company
Product Codes/Lot Numbers:
731030, 731032, 731034, 731036,731038, 731206, 731218, 731220, 731222, 731224, 731226, 731228, 731407, 731506, 731507, 731508, 731509, 731510, 731512, 731514, 731516, 731608, 731809, 732010, 732030, 732032, 732034, 732038, 732211, 732412, 732518, 732520, 732522, 732524, 732526, 732528, 733006, 733007, 733008, 733010, 733012, 733014, 733016, 733018, 733020, 733022, 733024, 733026, 733028, 733030, 733032, 733034, 733036, 733038, 733040, 733042, 734030, 734032, 734034, 734036, 734038, 735018, 735020, 735022, 735024, 735026, 735028, 736006, 736007, 736008, 736010, 736012, 736014, 736016, 736018, 736020, 736022, 736024, 736026, 736028, 736030, 736032, 736034, 736036, 736038, 731206/10/10, 731206/10/10RM, 731206/7, 731407/10/10, 731407/10/10RM, 731407/6X2RM, 731407/7, 731608/10/10, 731608/10/10RM, 731608/6, 731608/7, 731608/7X2RM, 731608/8/10, 731608/8/10RM, 731809/6, 732010/6, 732412/6, 7330303BL, 7330323BL, 7330343BL, 7330363BL, 7330383BL
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: Z-2266-2014
Related Recalls
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.
Product was labeled as a 30cm graft, when in fact the graft in the box was a 15cm graft.