Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cl
FDA device recall Z-1229-2013 · posted 2013-05-03 · Terminated
Recall details
- Recalling firm
- Stryker Endoscopy
- Reason for recall
- The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C.
- Action taken
- Stryker sent "Urgent Device Correction" letters dated March 27, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- GCX
- Quantity affected
- 147,921 - all sizes
- Distribution
- Worldwide Distribution: USA (nationwide) and countries of: Mexico, Portugal, Latin America, India, Greece, Taiwan, Singapore, New Zealand, Phillipines, Netherlands, France, Australia, Canada, Japan, S
- Date initiated
- 2013-03-27
- Date posted
- 2013-05-03
- Date terminated
- 2013-09-24
- Location
- San Jose, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) (K954726) | Stryker Endoscopy | 1995-11-29 |