Integra Large Rickham -Style Reservoir Rx Only Sterile for Single Use Only Integra NeuroSciences 311 Enterprise Drive Pl

FDA device recall Z-0622-2014 · posted 2014-01-03 · Terminated

Recall details

Recalling firm

Integra LifeSciences Corp.

Reason for recall

Integra became aware through an adverse complaint trend that Rickham Style Reservoirs with bent or broken connectors that were shipped in sleeve-type packages were found prior to use but after the sterile package was open.

Action taken

Integra sent an Urgent Voluntary Medical Device Recall letter dated November 13, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to inspect their inventory for the affected product and if located stop using immediately. Customers were asked to complete the attached form and return it to Integra as indicated and keep a copy of the form for their records. Once the form was received by Integra they will send an RMA number, directions to return the product, and input an order to replace the quantity they indicated on the form. Customers with questions were instructed to call 1-855-532-1723. For questions regarding this recall call 855-532-1723.

Root cause

Packaging

Status

Terminated

Product code

JXG

Quantity affected

78 packages

Distribution

Worldwide Distribution - USA including FL, NE, WI, WA, CT, ND, AL, NY, NH, OR, OK, MN, and TX. Internationally to Belgium, Czech Republic, Germany, France, Great Britian, Italy, Poland, and Portugal.

Date initiated

2013-11-13

Date posted

2014-01-03

Date terminated

2015-02-13

Location

Plainsboro, NJ