Cook Inc. Recalls Endoscopic Introducer/Extractor Due to Inadequate Reprocessing Instructions
Cook Inc. is recalling 46 Endoscopic Introducer/Extractor devices because their reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a documentation deficiency (insufficient reprocessing instructions) rather than a direct physical defect or contamination, fitting the 'Moderate' criteria for labeling/documentation issues without reported harm.
Plain-English summary
Cook Inc. has initiated a recall of 46 Endoscopic Introducer/Extractor devices (Catalog number J-EIE-051500). The recall was issued because the reprocessing instructions provided with the devices do not contain sufficient detailed information for the proper cleaning, disinfection, and sterilization of the products.
The devices were distributed nationwide within the United States and in several international locations, including Australia, Belgium, Canada, Finland, Germany, Guatemala, Hong Kong, India, Ireland, Japan, South Korea, Kuwait, Malaysia, Netherlands, New Zealand, Puerto Rico, Saudi Arabia, Taiwan, and the United Kingdom.
Healthcare facilities and users should stop using the affected devices and contact Cook Inc. for further instructions regarding the recall.
The recalled product
- Product
- Endoscopic Introducer/Extractor
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Endoscopy
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots Catalog numbers: J-EIE-051500
Distribution
Part of a larger recall action
This product is one of 5 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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