Z-0785-2016Class II

Bard Distaflo Vascular Bypass Graft

Name: Z-0785-2016 Bard Distaflo Vascular Bypass Graft
Creator: Bard Peripheral Vascular Inc
Published: 2016-01-05
License: https://open.fda.gov/license/

Bard Peripheral Vascular Inc / initiated 2016-01-05 / Terminated / root cause: labeling and UDI

FDA source

Bard Peripheral Vascular Inc began a recall of Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels on 2016-01-05. FDA classified it as Class II and gives the reason as "Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0785-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-05
Posted: 2016-02-09
Terminated: 2016-03-25
Recalling firm: Bard Peripheral Vascular Inc
Product: Bard Distaflo Vascular Bypass Graft; Product Code: DF6006SC; 8 mm x 60 cm. Intended for bypass or reconstruction of peripheral arterial blood vessels.
Product code: DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Reason for recall: Size mislabeling; the graft is labeled as a 6 mm diameter graft when the actual packaged product is an 8 mm graft.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: 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 [email protected]. 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
Quantity in commerce: 4 units
Distribution: Distributed in the states of AL, TX, and CA.
Product codes and lots: Product Code: DF6006SC Lot Number: VTZE1782

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0785-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0785-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-09
Z-0786-2016	Class II	Terminated	Voluntary: Firm initiated	2016-02-17	2016-02-09

Product code DSY

K983861Class IIDistaflo Bypass GraftImpra, Inc. / cleared 1998-11-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)