The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1460-2018·Announced 2018-04-25

Cook Vacuum Pump Recalled for Electrical Shock and Burn Risk

Cook Inc. is recalling 132 Cook Vacuum Pumps (K-MAR-5200-US) worldwide due to defective crimp connectors that may cause device failure, electric shock, or burns.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall involves a medical device with a defect that can cause electric shock or burns, which aligns with the rubric criterion for significant injury reports or high-risk physical hazards.

Plain-English summary

Cook Inc. is recalling 132 units of the Cook Vacuum Pump (Cook Aspiration Unit), model K-MAR-5200-US, GPN G51607. The device is intended for the aspiration of body fluids and cells, particularly for oocyte aspiration. The recall covers all lots of the product.

The recall was initiated because the pump was found to be constructed from crimp connectors that do not meet fixation wiring requirements. This defect can cause the device to fail to operate or result in electric shock or burns to the user.

The affected units were distributed worldwide, including in the USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela. Users should stop using the device and contact Cook Inc. for further instructions.

The recalled product

Product
Cook Vacuum Pump (Cook Aspiration Unit) K-MAR-5200-US, GPN G51607. Intended for the aspiration of body fluids and cells; in particular oocyte aspiration.
Manufacturer
Cook Inc.
Category
Medical Device — Surgical / Aspiration
Hazard
Affected units
132

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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 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 2 products in this recall →

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