Cook Inc. Recalls Double Flexible Tipped Wire Guides Due to Labeling Error
Cook Inc. is recalling 10,367 Double Flexible Tipped Wire Guides because the labels fail to state that the product is 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, which typically indicates a temporary or medically reversible adverse health consequence. The specific hazard is a labeling omission regarding heparin coating, which fits the criteria for moderate severity involving labeling errors without reported serious injury.
Plain-English summary
Cook Inc. is voluntarily recalling 10,367 units of the Double Flexible Tipped Wire Guide. The recall was initiated because the product labels do not state that the device is heparin-coated.
The affected products are distributed nationally. The recall includes items with Catalog # DTDW-/-BW and specific lot numbers ranging from F3749839 to F4916737 and NS4980257 to NS6098990.
Healthcare providers and consumers should check their inventory for these specific lot numbers. If the product is found, it should be removed from use and returned to the manufacturer or distributor according to standard recall procedures.
The recalled product
- Product
- Double Flexible Tipped Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 10,367
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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