Stryker Endoscopy FloControl Arthroscopy Pump Integrated Tubing, Model number 0350600006, for use with the FloControl Ar
FDA device recall Z-0652-2009 · posted 2009-01-21 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- HRX
- Quantity affected
- 1440 devices
- Distribution
- Nationwide.
- Date initiated
- 2008-10-01
- Date posted
- 2009-01-21
- Date terminated
- 2010-12-16
- Location
- San Jose, CA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ARTHROSCOPE ACCESSORIES (K944210) | Stryker Endoscopy | 1995-02-14 |