Recall Z-2413-2012— Davol, Inc., Subs. C. R. Bard, Inc.
Class II · Terminated
Class II FDA medical device recall by Davol, Inc., Subs. C. R. Bard, Inc., initiated 2012-09-04, terminated 2013-09-03. It names one FDA 510(k) clearance: K101851. Product: 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: 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.
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-09-04
- Terminated
- 2013-09-03
- Firm location
- Warwick, RI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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
Data sourced from openFDA. This site is unofficial and independent of the FDA.