—#143049

Product

Bard Distaflo Vascular Bypass Graft; Product Code: DF8006SC; 6 mm x 80 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.

FDA product code: DSY — Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device class: Class 2
Medical specialty: Cardiovascular
510(k) numbers: K983861
Affected lot / code info: Product Code: DF8006SC Lot Number: VTZE1783

Why it was recalled

Size mislabeling; the graft is a 6 mm diameter graft when the actual packaged product is an 8 mm graft.

Root cause (FDA determination)

Error in labeling

Action the firm took

Customer notification letters were sent on 01/05/2016. Customers were asked to not use the affected product, or further distribute it. Customers were asked to check all inventory locations for the affected product code, lot number combination listed. If customers further distributed any of the product they are requested to contact that location, advise them of the recall, and forward the listed instructions. The letter states to remove all identified product from the shelves. If no affected product is going to be returned the firm states to complete and return the attached form stating so. If customers have product it is requested that they also complete the attached form, and state the quantities and lot numbers in stock. The letter requests that customers call the firm's Recall Coordinator, Raye Seisinger, at 1-800-321-4254, option #2 ext. 2501 (M-F 6am to 3pm MST) or email raye.seisinger@crbard.com. Once all information has been verified the customer will be issued a Return Authorization or Consignment Recall Number to facilitate the expedient return of the product. The firm will provide replace product for returned product. Fax the attached form to the firm at 1-800-994-6772. If the customer cannot fax the firm they request that the Recall Coordinator be contact and provided the information verbally. The letter states a mailing label is enclosed to return the affected product. Customers are requested to amek the package as "recalled product" and include the XC or XH number. All products should be returned to the following shipping address: Bard Peripheral Vascular, Inc. 1415 W. 3rd St. Tempe, AZ 85281

Recalling firm

Firm: Bard Peripheral Vascular Inc
Address: 1625 W 3rd St, Tempe, Arizona 85281-2438

Distribution

Distribution pattern: Distributed in the states of AL, TX, and CA.

Timeline

Recall initiated: 2016-01-05
Posted by FDA: 2016-02-09
Terminated: 2016-03-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #143049. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.