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U.S. Department of Health and Human Services

Enforcement Report - Week of May 15, 2013

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Event Detail

Event ID 64682
Product Type Devices
Status Ongoing
Recalling Firm Stryker Endoscopy
City San Jose
State CA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-27
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern 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.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-490 Class II 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. 147,921 - all sizes Z-1236-2013
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip with No Holes, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-489 Class II 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. 147,921 - all sizes Z-1235-2013
Stryker Irrigator Reusable Tips: Vented Tip, 5mm X 45cm Non-Reflective with 30° Downward Bend At Proximal End. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-488s2 Class II 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. 147,921 - all sizes Z-1234-2013
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. Manufacturer Part Number: 250-070-488 Class II 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. 147,921 - all sizes Z-1233-2013
Stryker Irrigator Reusable Tips: 10mm X 32cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-484 Class II 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. 147,921 - all sizes Z-1231-2013
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. Manufacturer Part Number: 250-070-483 Class II 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. 147,921 - all sizes Z-1230-2013
Stryker Irrigator Reusable Tips: 5mm X 28cm Regular Tip, vented, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-482 Class II 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. 147,921 - all sizes Z-1229-2013
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 2 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-472 Class II 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. 147,921 - all sizes Z-1227-2013
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-471 Class II 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. 147,921 - all sizes Z-1226-2013
Stryker Irrigator Reusable Tips: 5mm X 32cm Aspiration Needle Tip. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-437 Class II 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. 147,921 - all sizes Z-1225-2013
Stryker Irrigator Reusable Tips: 5mm X 24cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-411 Class II 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. 147,921 - all sizes Z-1224-2013
Stryker Irrigator Reusable Tips: 5mm X 45cm Regular Tip, Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-408. Class II 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. 147,921 - all sizes Z-1222-2013
Stryker Irrigator Reusable Tips: 5mm X 32cm Tip Hydrodissection Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number:250-070-407 Class II 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. 147,921 - all sizes Z-1221-2013
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. Manufacturer Part Number: 250-070-403 Class II 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. 147,921 - all sizes Z-1219-2013
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. Manufacturer Part Number: 250-070-403 Class II 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. 147,921 - all sizes Z-1218-2013
Stryker Irrigator Reusable Tips: 3mm X 32cm Regular Tip, Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-491 Class II 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. 147,921 - all sizes Z-1237-2013
Stryker Irrigator Reusable Tips: 5mm X 32cm Hydrodissection Tip, Non-Reflective Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-487 Class II 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. 147,921 - all sizes Z-1232-2013
Stryker Irrigator Reusable Tips: 2mm X 34cm Regular Tip with No Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-473 Class II 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. 147,921 - all sizes Z-1228-2013
Stryker Irrigator Reusable Tips: 5mm X 32cm Regular Tip , Non-Vented, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-409 Class II 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. 147,921 - all sizes Z-1223-2013
Stryker Irrigator Reusable Tips: 10mm X 32cm Pool Suction Tip, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative site during laparoscopic surgery. Manufacturer Part Number: 250-070-404. Class II 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. 147,921 - all sizes Z-1220-2013
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