Cook Inc. Recalls Movable Core Wire Guide Due to Labeling Error
Cook Inc. is recalling 21,913 Movable 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, but the source text identifies the issue as a labeling omission regarding heparin coating without reporting any illnesses or injuries, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Cook Inc. is recalling 21,913 units of the Movable Core Wire Guide. The recall was initiated because the product labels did not state that the devices are heparin-coated.
The affected products were distributed nationally. The recall covers specific catalog numbers and lot ranges, including TCMTNA-/-BH, TMT-/-BH, and TSFNA-/-BH.
Healthcare providers and consumers should check their inventory for these specific catalog numbers and lot ranges. 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
- Movable Core Wire Guide
- Manufacturer
- Cook Inc.
- Hazard
- Affected units
- 21,913
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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