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U.S. Department of Health and Human Services

Class 2 Device Recall 3.5mm Super 90S SERFAS Energy Suction Probe

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 Class 2 Recall
3.5mm Super 90S SERFAS Energy Suction Probe
see related information
Date Posted February 09, 2009
Recall Status1 Terminated on June 22, 2009
Recall Number Z-0972-2009
Recall Event ID 50825
Premarket Notification
510(K) Number
K041810 
Product Classification Electrosurgical, Cutting & Coagulation & Accessories - Product Code GEI
Product Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico
Code Information 08065AE2, 08066AE2, 08070AE2, 08079AE2, 08084AE2, 08086AE2, 08080AE2, 08085AE2, 08087AE2, 08088AE2, 08129AE2, 08128AE2, 08130AE2, 08136AE2, 08137AE2, 08140AE2, 08149AE2, 08154AE2, and 08157AE2
Recalling Firm/
Manufacturer
Stryker Endoscopy
5900 Optical Ct
San Jose, California 95138-1400
For Additional Information Contact Jennifer Scott
408-754-2124
Manufacturer Reason
for Recall
The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On 6/20/08, the firm initiated the recall and its notification was via Urgent: Device Removal letters explaining the reason for the recall. The letter recommended that recipients of the letter inspect their inventory for the part number/lot numbers listed and quarantine any of the affected product. Affected products should be returned to Stryker Endoscopy using the Pre-paid shipping label provided. Customers should call Stryker Endoscopy's Customer Service Department at 1-800-624-4422 for replacement product. Importantly, customers should sign and complete the enclosed "acknowledgment of receipt" card and return it to Stryker Endoscopy or fax it to 408-754-2521 with the customer's account info included. If there are any questions regarding the notice, a Regulatory Affairs Representative should be contacted at 408-754-2161 or 408-754-2000.
Quantity in Commerce 2463 units
Distribution Worldwide Distribution.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = GEI and Original Applicant = Stryker Endoscopy
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