Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip recall
Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative…
Why was Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Manufacturer Part Number: 250-070-471
- Product
- Stryker Irrigator Reusable Tips: 2mm X 32cm Regular Tip with 1 Hole, Metal Finish. Suction irrigator tips aid in cleaning and clearing the operative…
- Recalling firm
- Stryker Endoscopy
- 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.
- Recall date
- May 15, 2013
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)