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U.S. Department of Health and Human Services

Class 2 Device Recall FloControl Arthroscopy Pump

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 Class 2 Device Recall FloControl Arthroscopy Pumpsee related information
Date Initiated by FirmOctober 01, 2008
Date PostedJanuary 21, 2009
Recall Status1 Terminated 3 on December 16, 2010
Recall NumberZ-0652-2009
Recall Event ID 50141
510(K)NumberK944210 
Product Classification arthroscopy pump tubing - Product Code HRX
ProductStryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.
Code Information Lot number: 08E0451
Recalling Firm/
Manufacturer		 Stryker Endoscopy
5900 Optical Ct
San Jose CA 95138-1400
For Additional Information Contact
408-754-2124
Manufacturer Reason
for Recall		Unable to pump fluids. Silicone tubing is stiffer than usual, resulting in motor defect message, leading to inability to pump saline through tubes for surgery.
FDA Determined
Cause 2		Process control
ActionStryker Endoscopy initiated the recall 10/01/2008. Information gathered and recall packets sent via FedEx to all affected accounts. Packets included advisory notices and acknowledgement card, as well as shipping labels to return product. Each account was instructed to locate and quarantine product for return to Stryker endoscopy. Sales representatives received a voicemail/email notification that included a list of all affected accounts.
Quantity in Commerce1440 devices
DistributionNationwide.
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.
510(K) Database510(K)s with Product Code = HRX
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