LIGACLIP Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk non-sterile Product Usage: The LIGACLIP Endos

FDA device recall Z-1777-2013 · posted 2013-07-19 · Terminated

Recall details

Recalling firm

Ethicon Endo-Surgery Inc

Reason for recall

Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP 10mm M/L Endoscopic Rotating Multiple Clip Applier (ER320) due to potential clip formation and feeding issues which may result in improper clip formation, vessel damage and/or insufficient occlusion of the vessel or other structure

Action taken

Ethicon sent an Urgent : Medical Device Recall letter dated April 30, 2013 to all primary and secondary consignees via overnight UPS to allow tracking of the receipt. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately and return affected products for credit. This credit is intended to facilitate replacement purchase. For questions contact your local representative or call Ethicon Customer Support Center at 1-877-384-4266 option 6.

Root cause

Under Investigation by firm

Status

Terminated

Product code

GDO

Quantity affected

10,488

Distribution

Worldwide Distribution - USA Nationwide to all fifty (50) states, and internationally including the following countries: ARGENTINA, ARGENTINA, BAHRAIN, BELGIUM, BRAZIL, CANADA, CHILE, CHINA, COLOMBIA,

Date initiated

2013-04-12

Date posted

2013-07-19

Date terminated

2014-05-01

Location

Cincinnati, OH

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