Recall Z-1219-2013— Stryker Endoscopy
Class II · Terminated
Class II FDA medical device recall by Stryker Endoscopy, initiated 2013-03-27, terminated 2013-09-24. It names one FDA 510(k) clearance: K954726. Product: Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery.. Reason: 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..
- Recalling firm
- Stryker Endoscopy
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-03-27
- Terminated
- 2013-09-24
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip, Vented, Metal 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.