Recall Z-0652-2009 ยท HRX Arthroscope
Stryker Endoscopy
Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Arthroscopy Pump.
| Date | Jan 21, 2009 (initiated Oct 1, 2008) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| 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. |
| Quantity | 1440 devices |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K944210 | ARTHROSCOPE ACCESSORIES Stryker Endoscopy, Feb 14, 1995 |