The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0955-2018·Announced 2018-03-21

Cook Inc. Recalls Disposable Reuter Tip Deflecting Wire Guides for Labeling Error

Cook Inc. is recalling 18,398 units of Disposable Reuter Tip Deflecting Wire Guides because the labels fail to state that the product is heparin-coated.

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 2/5 (Moderate).

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 hazard is a labeling error regarding heparin coating, which is a moderate risk factor but does not meet the criteria for Severe or Critical severity as no injuries or deaths are reported.

Plain-English summary

Cook Inc. is recalling 18,398 units of the Disposable Reuter Tip Deflecting Wire Guide. The recall was initiated because the product labels do not state that the device is heparin-coated. This omission may prevent healthcare providers from being fully aware of the product's coating during use.

The affected products are identified by Catalog # DTDW-/-BW. The specific affected lots include 3730008 through 6164931, F4374635 through F4791430, and NS5034700 through NS5562947. The products were distributed nationally.

Healthcare facilities and consumers should check their inventory for these specific lot numbers and catalog codes. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations. No specific instructions for return are provided in the source text, but standard recall procedures apply.

The recalled product

Product
Disposable Reuter Tip Deflecting Wire Guide
Manufacturer
Cook Inc.
Category
Medical Device — Interventional Cardiology
Hazard
Affected units
18,398

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.

See all 20 products in this recall →

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