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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
View Details
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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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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. Class II

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.

Stryker Endoscopy 20130327 Terminated
Distributed: 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.
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