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U.S. Department of Health and Human Services

Class 2 Device Recall Sterile Sheath

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 Class 2 Device Recall Sterile Sheathsee related information
Date Initiated by FirmSeptember 23, 2009
Date PostedNovember 23, 2009
Recall Status1 Terminated 3 on March 08, 2010
Recall NumberZ-0403-2010
Recall Event ID 53694
Product Classification Implantable staple. - Product Code GDW
ProductSterile Sheath, product code SS01.
Code Information all codes
Recalling Firm/
Manufacturer		 Surgical Devices/Covidien
60 Middletown Ave
North Haven CT 06473-3908
For Additional Information ContactCustomer Service
866-769-3763
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe 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.
Quantity in Commerce105 units
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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