Class 2 Device Recall Gelweave (TM) Vascular Prostheses

• Date Initiated by Firm: July 15, 2014
• Date Posted: August 18, 2014
• Recall Status: Terminated on March 19, 2015
• Recall Number: Z-2266-2014
• Recall Event ID: 68952
• Product Classification: Prosthesis, vascular graft, of 6mm and greater diameter - Product Code DSY
• Product: Gelweave (TM) Vascular Prostheses; Manufactured by - VASCUTEK Ltd; a TERUMO company
• Code Information: 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
• Recalling Firm/ Manufacturer: Vascutek, Ltd.; Newmains Avenue; Inchinnan United Kingdom
• For Additional Information Contact: 800-262-3304 Ext. 6056
• Manufacturer 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).
• FDA Determined 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 If you find that the cautery is out of date, remove and discard the cautery.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 supplied as a separate item, please contact your local sales representative for a referral. C.Vascutek are taking this opportunity to reinforce the cautions from the Gelweave TM Vascular Prostheses IFU regarding soaking of the graft in saline to prevent focal burning if a cautery is to be used. This statement is already included in the IFU and now appears in bold, red font to ensure appropriate awareness. This notice needs to be passed on to all persons who need to be aware within your organization or to any organization where the devices have been transferred or distributed. Please maintain awareness of this Field Safety Notice while all actions are taken in your organization and until these products are provided without the cautery. Please return the User Return Slip by e-mail or fax to the Distributor's address given on page 3. This action by Vascutek Ltd. is being taken with the knowledge of the National Competent Authority¿ Medicines and Healthcare Products Regulatory Agency (MHRA). If you have any further questions or comments, please do not hesitate to contact us at tcvs.recall@terumomedical.com. Return Completed Form immediately fax to (734) 741-6149. If required, your Vascutek Ltd. representative can discuss and provide more information on the use of cautery with Vascutek products. For further questions call (800) 262-3304 ext. 6056
• Quantity in Commerce: 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.
• Total Product Life Cycle: TPLC Device Report

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.