Cook Multi-Use Holmium Laser Fibers Recalled for Reprocessing Instruction Deficiencies
Cook Inc. is recalling 4,369 multi-use holmium laser fibers because the current instructions for use do not provide sufficient detail for proper cleaning, disinfection, and sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is classified as Low severity because it addresses a documentation issue (insufficient reprocessing instructions) rather than a physical defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Cook Inc. is recalling 4,369 units of Cook Multi-Use Holmium Laser Fibers. These devices are supplied sterilized by ethylene oxide gas in peel-open packages. The recall involves specific model codes including HLF-M273-H30, HLF-M365-H30, HLF-M550-H30, HLF-M940-H30, HLF-M273-HSMA, HLF-M365-HSMA, HLF-M550-HSMA, and HLF-M940-HSMA.
The recall was initiated to correct the product Instructions for Use. The current reprocessing instructions do not provide sufficient detailed information for the cleaning, disinfection, and sterilization of these products. This documentation issue affects the ability of healthcare facilities to properly reprocess the devices between uses.
The affected products were distributed domestically to numerous U.S. states and internationally to a wide range of countries, including Canada, the United Kingdom, Germany, and Australia. Healthcare facilities and consumers who have these specific laser fibers should stop using them and contact Cook Inc. for further instructions regarding the corrected documentation.
The recalled product
- Product
- Cook Multi-Use Holmium Laser Fibers, Supplied sterilized by ethylene oxide gas in peel-open packages
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Laser Fibers
- Affected units
- 4,369
Distribution
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