Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.
FDA Recall Z-0652-2009 · Posted 2009-01-21
Recalling FirmStryker Endoscopy
Recall StatusTerminated
Product CodeHRX
Date Initiated2008-10-01
Date Terminated2010-12-16
Product Quantity1440 devices
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.
Firm Action
Stryker 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.
Root Cause
Process control
Distribution Pattern
Nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.