Recall Z-1683-2014— Davol, Inc., Subs. C. R. Bard, Inc.

Name: FDA recall Z-1683-2014
Creator: U.S. Food and Drug Administration
Published: 2014-04-24

Class II · Terminated

Class II FDA medical device recall by Davol, Inc., Subs. C. R. Bard, Inc., initiated 2014-04-24, terminated 2015-12-23. It names one FDA 510(k) clearance: K122436. Product: Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.. Reason: Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal..

Recalling firm: Davol, Inc., Subs. C. R. Bard, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-04-24
Terminated: 2015-12-23
Firm location: Warwick, RI, United States

510(k) clearances named in this recall

1 on FDA's record

K122436 — COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEMC.R. Bard, Inc.·cleared 2012-11-02

K-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

Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.

Reason for recall

Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.

Data sourced from openFDA. This site is unofficial and independent of the FDA.