| Class 2 Device Recall SurgAssist System Circular Stapler DLU 33mm |  |
Date Initiated by Firm | November 20, 2003 |
Date Posted | December 19, 2003 |
Recall Status1 |
Terminated 3 on February 10, 2004 |
Recall Number | Z-0253-04 |
Recall Event ID |
27764 |
510(K)Number | K032701 |
Product Classification |
Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp - Product Code GWD
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Product | SurgAssist System Circular Stapler DLU 33mm |
Code Information |
Product Code CS33, Lot numbers LC-000134, LC-000135, LC-000136, LC-000140, and LC-000144. |
Recalling Firm/ Manufacturer |
Power Medical Interventions 110 Union Square Dr New Hope PA 18938-1365
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For Additional Information Contact | Emmanuel Tribie 267-775-8100 |
Manufacturer Reason for Recall | improper staple formation or anvil jam |
FDA Determined Cause 2 | Other |
Action | On 11/20/03, the recalling firm sent recall notices via overnight carrier to all customers who have been shippped and/or sold the product. The recall notice requested the return of the devices. |
Quantity in Commerce | 350 units |
Distribution | The products were shipped to medical facilities and sales representatives nationwide. The product was also shipped to distributors in the United Kingdom, France, Scotland, Belgium, Germany, Israel, Italy, Japan, Spain, Portugal, and Sweden. |
Total Product Life Cycle | TPLC Device Report |
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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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510(K) Database | 510(K)s with Product Code = GWD
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