Z-1461-2018Class II

Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body...

Name: Z-1461-2018 Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body...
Creator: Cook Inc.
Published: 2018-03-22
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2018-03-22 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration on 2018-03-22. FDA classified it as Class II and gives the reason as "Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1461-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-22
Posted: 2018-04-19
Terminated: 2020-05-13
Recalling firm: Cook Incorporated
Product: Cook Vacuum Pump ( Cook Aspiration Unit) K-MAR-5200-US, GPN G49275. Intended for the aspiration of body fluids and cells, in particular oocyte aspiration.
Product code: MQG Accessory, Assisted Reproduction
Reason for recall: Pump was found to be constructed from crimp connectors that do not meet the fixation wiring requirements and can cause failure of the device to operate or electric shock or burn to the user.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: An Urgent: Medical Device Correction letter, dated March 20, 2018, was sent to consignees. The letter identified the affected device and provided a description of the problem. The firm stated that it would be replacing the mains wiring for each unit. An authorized service agent will contact customers to arrange for the affected devices to be corrected. Customers are to follow the instructions regarding the residual current device (RCD) provided in the letter, while they are waiting for their devices to be corrected. Additionally, customers should complete the Acknowledgement and Receipt Form within 5 business days of receiving the letter. Questions or concerns should be directed to Cook Medical Capital Equipment Service at 855-207-7214.
Quantity in commerce: 2,267
Distribution: Worldwide Distribution -- USA, Argentina, Bolivia, Brazil, Canada, Colombia, Guatemala, Mexico, Panama, Peru, Uruguay, and Venezuela.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1461-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1460-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-19
Z-1461-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-25	2018-04-19

Product code MQG

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)