Medical Device Recall: Z-0397-2010

FDA Recalls dataset · Firm: Surgical Devices/Covidien · Status: Terminated

Recall Action Class: N/A Date Initiated: 2009-09-23 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0397-2010.

Recall Res Number
Z-0397-2010
Recalling Firm / Manufacturer
Surgical Devices/Covidien
FEI Number
1219930
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2009-09-23
Date Posted
2009-11-23
Date Terminated
2010-03-08
Product Code
GDW
Event Number
53694
Product Quantity
1100 units
Product Description FlexShaft, product code FS14; FlexShaft II, product code FS214; FlexShaft III, product code FS312; FlexShaft III Sterilization Connector Guard, product code FS3SCG; FlexShaft II Reconditioned, product code FS214RC; Manual Release for FlexShaft II & III, product code MR14.
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 Details 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.
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.
Code Information / Serial Numbers all codes

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