Bard Ventralight" ST Mesh with Echo PS" 4.5" Circle Reorder Number: 5955450 Indicated for use in the reconstruction of s
FDA device recall Z-1689-2014 · posted 2014-06-02 · Terminated
Recall details
- Recalling firm
- Davol, Inc., Subs. C. R. Bard, Inc.
- Reason for recall
- Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
- Action taken
- 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.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- GCJ
- Distribution
- Worldwide Distribution - USA (nationwide) and Internationally to AUSTRIA, BELGIUM, CANADA, CYPRUS, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, IRELAND, ITALY, LUXEMBOURG, NETHERLANDS, NORWAY, POLAND, P
- Date initiated
- 2014-04-24
- Date posted
- 2014-06-02
- Date terminated
- 2015-12-23
- Location
- Warwick, RI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| COMPOSIX L/P MESH WITH ECHO PS POSITIONING SYSTEM VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM (K122436) | C.R. Bard, Inc. | 2012-11-02 |