Agency classClass IIOur severity:Moderate FDA (Devices)·Z-2537-2017·Announced 2017-06-21

Cook Inc. Recalls Clarke-Reich Laparoscopic Knot Pushers Due to Reprocessing Issues

Cook Inc. is recalling 178 Clarke-Reich Laparoscopic Knot Pushers because the reprocessing instructions do not provide sufficient detail for cleaning, disinfection, and sterilization.

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. The hazard is a documentation deficiency (insufficient reprocessing instructions) rather than a direct defect causing injury, and no illnesses or injuries are reported in the source text.

Plain-English summary

Cook Inc. is recalling 178 units of the Clarke-Reich Laparoscopic Knot Pusher (Catalog number J-CRKP-042900). The recall was initiated 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 affected devices have been 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: Clarke-Reich Laparoscopic Knot Pusher
Manufacturer: Cook Inc.
Category: Medical Device — Surgical Instrument
Hazard: mis-labeling
infection-risk
Affected units: 178

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-CRKP-042900

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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.

See all 5 products in this recall →

Same manufacturer · Cook Inc.

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Same hazard · mis labeling