OptiLite Multi-Use Holmium Laser Fibers recall
OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 …
Why was OptiLite Multi-Use Holmium Laser Fibers recalled?
Cook Inc. is initiating a voluntary recall of the OptiLite Multi-Use Holmium Laser Fibers because it has been identified that the reprocessing instructions do not provide sufficiently detailed information for the cleaning, disinfection, and sterilization of these products.
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?
OptiLite Multi-Use Holmium Laser Fibers, Catalog Numbers followed by GPN: HLF-M273-CNV, G48611 HLF-M273-SMA, G48522 HLF-M365-CNV, G48613 HLF-M365-SMA, G48618 HLF-M550-CNV, G48615 HLF-M550-SMA, G48619 HLF-M940-CNV, G48617 HLF-M940-SMA, G48621 HLF-M273-CNV-CAN, G51777 HLF-M273-SMA-CAN, G51785 HLF-M365-CNV-CAN, G51778 HLF-M365-SMA-CAN, G51786 HLF-M550-CNV-CAN, G51779 HLF-M550-SMA-CAN, G51787 HLF-M940-CNV-CAN, G51780 HLF-M940-SMA-CAN, G51788
- Product
- OptiLite Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages Product Usage: Used with the Odyssey 30 …
- Recalling firm
- Cook Inc.
- Quantity
- 10,415
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AK AL AZ CA CO FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO MS MT NC NJ NY OH OR PA SC SD TN TX WA WI Foreign: Australia, Bolivia, Brazil, Canada, Chile, Columbia, Cyprus, Czech Republic, Germany, Dominican Republic, Greece, Hong Kong, Ireland, Israel, India, Iran, Jordan, Kuwait, Kazakhstan, Lebanon, Sri Lanka, Latvia, Libya, Mexico, Malaysia, New Zealand, Oman, Panama, Peru, Portugal, Serbia, Turkey, Trinidad and Tobago, Taiwan, and Venezuela. VA/DOD: Yes- see below
- Recall date
- June 21, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)