Cook Inc. Recalls Fixed Core Wire Guide Due to Heparin Labeling Error
Cook Inc. is recalling 601,778 Fixed Core Wire Guides because the labels failed to state that the products are heparin-coated.
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, and the source text identifies a labeling error regarding heparin coating without reporting specific injuries or illnesses, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
Cook Inc. is recalling 601,778 units of the Fixed Core Wire Guide. The recall was initiated because the product labels do not state that the device is heparin-coated.
The affected products were distributed nationally. The recall covers specific catalog numbers including C-SCF-/-BH, C-SF-/-BH, SF-/-BH, THSCF-/-BH, THSF-/-BH, TSCF-/-BH, TSCFR-/-BH, and TSF-/-BH. Affected lot codes range from 3730001 to 6164916, F3729969 to F4922979, and NS4928020 to NS6203182, among other specified ranges.
Healthcare providers and patients should check their inventory and patient records for these specific catalog and lot numbers. If the product is found, it should be removed from use and returned to Cook Inc. or the distributor in accordance with the recall instructions.
The recalled product
- Product
- Fixed Core Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 601,778
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 20 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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