Weck Hemoclip Plus Ligating Clips, Rx Only, Sterile, Teleflex Medical, RTP, NC 27709 USA. The use of the reusable Telefl

FDA device recall Z-0157-2009 · posted 2008-09-16 · Terminated

Recall details

Recalling firm

Telefelx Medical

Reason for recall

A hole in the sterile unit blister pack was detected that would compromise sterility.

Action taken

Consignees were notified via UPS next day on/about August 22, 2008. They were instructed to cease use and distribution and quarantine all affected product immediately. If they have any of the affected product they were instructed to return all it to Teleflex Medical via provided UPS-Ground. An Acknowledgement form was provided to be completed and returned via fax to Teleflex Medical to confirm receipt of the notification and amount of product on hand for return. A second mailing to non-responding customers on the consignee list will be made approximately four to six weeks after the first mailing. A third mailing to non-responding customers on the consignee list will be made approximately four to six weeks from the second mailing. Consignees also may be contacted by phone, e-mail, or fax. A record of these contacts will be maintained. Upon return to Teleflex Medical, product will be quarantined, assessed for recall effectiveness, and either reworked or destroyed. Contact Telefex Medical at 1-800-334-9751 ext. 8066 for assistance.

Root cause

Packaging process control

Status

Terminated

Product code

FZP

Quantity affected

786036 (total pieces)

Distribution

Nationwide

Date initiated

2008-08-22

Date posted

2008-09-16

Date terminated

2012-03-15

Location

Durham, NC

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