Microline Renew Fenestrated Control Tip Grasper, Single Patient Use, Product Number: 3222 The ReNew Fenestrated Grasper

FDA device recall Z-1635-2014 · posted 2014-05-20 · Terminated

Recall details

Recalling firm

Microline Surgical

Reason for recall

Grasper jaw may break when force is applied to the jaw

Action taken

Microline Surgical sent an Recall Notice dated April 14, 2014, via overnight mail to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Immediately examine your inventory and quarantine product subject to this recall. In addition, if you have further distributed this product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. Please contact Microline Customer Service ( 978) 922-9810 for a RGA number to return all unused product. This recall should be carried out to the hospital level. Please complete and return the enclosed response form as soon as possible.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GEI

Quantity affected

540 units

Distribution

Worldwide Distribution - US including the states of TX, IL, TN and NY, and the country of Chile.

Date initiated

2014-04-14

Date posted

2014-05-20

Date terminated

2015-09-02

Location

Beverly, MA

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