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Terminated

Intelligent Reload, 45 mm Blue, product code iR45B; Intelligent Reload, 45 mm Green, product code iR45G; Intelligent Reload Mid Cut 45mm Blue, product code iR45MB; Intelligent Reload Mid Cut 45mm Green, product code iR45MG; Intelligent Reload, 45 mm, Vascular, product code iR45V; Intelligent Reload, 60 mm Blue, product code iR60B; Intelligent Reload, 60 mm Green, product code iR60G; Intelligent Reload Mid Cut 60mm Blue, product code iR60MB; Intelligent Reload Mid Cut 60mm Green, product code iR60MG; Intelligent Reload, 60 mm Blue No Knife, product code iR60B4.

FDA Recall Z-0405-2010 · Posted 2009-11-23

Recalling FirmSurgical Devices/Covidien
Recall StatusTerminated
Product CodeGDW
Date Initiated2009-09-23
Date Terminated2010-03-08
Product Quantity21,958units

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.

Firm Action

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

Distribution Pattern

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, Portugal, India, Austria, Turkey, and Greece.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K071708I45, I45S, I60, AND I60SPower Medical Interventions, Inc. · 2007-09-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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