Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reported: May 15, 2013 Initiated: March 27, 2013 #Z-1230-2013
Product Description
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.
Reason for Recall
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Details
- Recalling Firm
- Stryker Endoscopy
- Units 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, Scandinavia, Iberia, Brasil, Romania, South Africa, Chile, Korea, China.
- Location
- San Jose, CA
Frequently Asked Questions
What product was recalled? ▼
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.. Recalled by Stryker Endoscopy. Units affected: 147,921 - all sizes.
Why was this product recalled? ▼
The pre-vacuum steam sterilization (wrapped method) temperature in the Instructions for Use incorrectly listed 121-123¿C , instead of the correct 132-133¿C.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 15, 2013. Severity: Moderate. Recall number: Z-1230-2013.
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