Z-1689-2014Class II

Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the...

Name: Z-1689-2014 Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the...
Creator: Davol, Inc., Subs. C. R. Bard, Inc.
Published: 2014-04-24
License: https://open.fda.gov/license/

Davol Inc., Sub. C.R. Bard, Inc. / initiated 2014-04-24 / Terminated / root cause: packaging

FDA source

Davol, Inc., Subs. C. R. Bard, Inc. began a recall of Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the... on 2014-04-24. FDA classified it as Class II and gives the reason as "Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1689-2014
Classification: Class II
Status: Terminated
Initiated: 2014-04-24
Posted: 2014-06-02
Terminated: 2015-12-23
Recalling firm: Davol Inc., Sub. C.R. Bard, Inc.
Product: Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Product code: GCJ Laparoscope, General & Plastic Surgery
Reason for recall: Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: Davol, Inc., Subs. C. R. Bard, Inc.sent an Urgent Medical Device Recall letter dated April 28, 2014, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to examine their inventory and quarantine product subject to the recall, contact Davol Customer Service at 1-800-556-6275 or C.R. Bard's Medical Services and Support Department at 1-800-562-0027 for instructions on how to return the product to Davol, Consignees were also instructed to complete and return the recall effectiveness check form, and notify their customers if the product was further distributed. For questions regarding this recall call 1-800-556-6275.
Distribution: Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, PORTUGAL, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, and UNITED KINGDOM
Product codes and lots: Lot Number: HUXH0535, HUXH0696, HUXK0747

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1689-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1682-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1683-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1684-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1685-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1686-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1687-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1688-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1689-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1690-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1691-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1692-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1693-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1694-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1695-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02
Z-1696-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code GCJ

K122436Class IIComposix L/p Mesh with Echo Ps Positioning System Ventralight St Mesh with Echo Ps Positioning SystemC.R. Bard, Inc. / cleared 2012-11-02

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)