Z-1565-2020Class II

Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number...

Name: Z-1565-2020 Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number...
Creator: Cook Inc.
Published: 2020-03-06
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2020-03-06 / Terminated

FDA source

Cook Inc. began a recall of Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643 on 2020-03-06. FDA classified it as Class II and gives the reason as "The printed expiration dates are incorrect". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1565-2020
Classification: Class II
Status: Terminated
Initiated: 2020-03-06
Posted: 2020-03-24
Terminated: 2020-12-18
Recalling firm: Cook Incorporated
Product: Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Product code: GBX Catheter, Irrigation
Reason for recall: The printed expiration dates are incorrect.
FDA root cause: Under Investigation by firm
Action: An Urgent Medical Device Recall notification letter dated 3/6/2020 was distributed to customers. Actions to be Taken by the Customer 1.Examine inventory immediately to determine if you have affected product(s) and quarantine anyaffected product that remains unused. Immediately cease all distribution and use of this product. 2.Return the affected product(s) to Cook Medical with a copy of the Acknowledgement andReceipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form forreturn instructions. Note: Unaffected products that are returned will not be credited. 3.Please complete the Acknowledgement and Receipt Form within 5 business days of receivingthis letter. Even if you do not have affected product(s) on hand, you must still complete theAcknowledgement and Receipt Form and return via fax (812.339.7316) or email([email protected]). 4.This notice must be shared with appropriate personnel, including down to the user level, withinyour organization or with any organization where the potentially affected devices have beentransferred. 5.Immediately report adverse events to Cook Medical Customer Relations by phone at800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (EasternTime), or by email to: [email protected].
Quantity in commerce: 25
Distribution: The products were distributed to the following US states: CO, DE, MD, MN, NC, NV, and WV. The products were distributed to the following foreign countries: Canada.
Product codes and lots: Lot Number 10119247; UDI: (01)00827002106437(17)921110(10)10119247

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1565-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1565-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-24
Z-1566-2020	Class II	Terminated	Voluntary: Firm initiated	2020-04-01	2020-03-24

Product code GBX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)