Z-2413-2012 Class II Terminated

Recalled by Davol, Inc., Subs. C. R. Bard, Inc. — Warwick, RI

Recall Details

Product Type
Devices
Report Date
September 26, 2012
Initiation Date
September 4, 2012
Termination Date
September 3, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
49 units

Product Description

Bard Ventralight ST Mesh. - Ellipse 7" x 9" (17.8 cm x 22.9 cm) Product Code 5954790. The Bard Ventralight ST Mesh is a dual-component (absorbable and nonabsorbable) sterile prosthesis. The device classification name is "Mesh, Surgical, Polymeric." It is in tented for use in the reconstruction of soft tissue deficiencies, such as for the repair of hernias.

Reason for Recall

Mislabeled: The 8" x 10" package contains 7" x 9" VENTRALIGHT ST Mesh product and the 7" x 9" package contains 8" x 10" VENTRALIGHT ST Mesh

Distribution Pattern

Nationwide Distribution.

Code Information

Lot # HUWE1780