Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecolo

FDA device recall Z-1063-2013 · posted 2013-04-05 · Terminated

Recall details

Recalling firm

Covidien LP

Reason for recall

Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

Action taken

Covidien notified customers with an Urgent Medical Device Recall notification on February 11, 2013. The letter identified the affected product and the reason for the recall. Accounts were requested to quarantine and discontinue use of the affected devices, and notify Universal Loading Unit 30mm-2.0mm users of this recall. Customers should follow the instructions provided in order to return the affected product. Customers are to complete and return the Product Return Form regardless if they have any affected product or not. For questions regarding the RGA I return process, please contact Covidien Customer Service, M-F, 8 am - 6:30 pm ET at (800) 962-9888, option 1, and then option 2.

Root cause

Process control

Status

Terminated

Product code

GDW

Quantity affected

6,751 units

Distribution

Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.

Date initiated

2013-02-11

Date posted

2013-04-05

Date terminated

2014-03-20

Location

North Haven, CT

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