Weck, DermaHook (12mm), Neuro Elastic Retractors, 6 per Package, 10 Packages per Sales Units, 10 Sales Units per Shipper

FDA device recall Z-0678-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Teleflex Medical

Reason for recall

Teleflex Medical received complaints that the elastic bands are breaking, cracking and /or deteriorating prior to their expiration date. If the elastic bands break during use there is a chance for operative exposure, loss of the band in the operative field as well as inadvertent needle stick.

Action taken

The firm, Teleflex Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTIFICATION" letter dated December 6, 2011 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to immediately discontinue distribution and quarantine any products with the listed catalog and lot numbers; communicate this recall to any of their customers who have received the product; have their customers return the affected product together with a completed Recall Acknowledgement Form to Teleflex Medical, if an alternative approach is needed, contact Teleflex Medical Customer Service for more information at 1-866-246-6990; complete and return the Recall Acknowledgement Form via fax to 1-866-804-9881, Attn: Customers Service even if they and their customers have no affected stock. If you have any questions, feel free to contact your local sales representative or Customer Service at 1-866-246-6990.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GDG

Quantity affected

to be obtained

Distribution

Nationwide distribution.

Date initiated

2011-12-06

Date posted

2012-01-11

Date terminated

2014-05-20

Location

Research Triangle Park, NC