Endoscopic Linear Cutter Reload, 45 mm Blue, product code PLCR45B; Endoscopic Linear Cutter Reload, 45 mm Green, product

FDA device recall Z-0400-2010 · posted 2009-11-23 · Terminated

Recall details

Recalling firm

Surgical Devices/Covidien

Reason for recall

Lack of assurance that products were manufactured under GMPs. This action is being undertaken due to certain products potentially exhibiting compromised staple formation or cutting which in some instances may result in extended surgical time for the patient.

Action taken

The recalling firm issued an Urgent Medical Device Recall letter dated 9/22/09 to all customers. The letter informed customers that Covidien acquired PMI, about the problem with the products, and about the need to return any products remaining inventory. Customers were asked to return the entire inventory of Power Medical Interventions product, regardless of its expiration date. This process can be initiated by contacting Power Medical Innovations customer service at 1-866-769-3763.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

GDW

Quantity affected

95 units

Distribution

The products were shipped medical facilities nationwide. The product was also shipped to distributors in Canada, Japan, Germany, Ireland, Italy, Spain, Taiwan, Belgium, Sweden, Netherlands, Israel, Po

Date initiated

2009-09-23

Date posted

2009-11-23

Date terminated

2010-03-08

Location

North Haven, CT