Recall Z-1233-2013 ยท GCX Apparatus, Suction, Operating-Room, Wall Vacuum Powered
Stryker Endoscopy
Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
| Date | May 3, 2013 (initiated Mar 27, 2013) |
| Status | Terminated |
| Reason | The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123C , instead of the correct 132-133C. |
| Root cause | Error in labeling |
| Action | 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. |
| Quantity | 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, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K954726 | STRYKER STRYKEFLOW SUCTION IRRIGATOR (MODIFICATION) Stryker Endoscopy, Nov 29, 1995 |