Pericardiocentesis Set, Irrigation Catheter, Reference Part… recallZ-1565-2020 · Cook Inc. · initiated Mar 6, 2020
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Cook Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The printed expiration dates are incorrect.
FDA root cause category: Under Investigation by firm
What the company is doing
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].
Recall details
- Recall number
- Z-1565-2020
- Status
- Terminated
- Initiated by the company
- Mar 6, 2020
- Recalling firm
- Cook Inc.
- Quantity
- 25
- Product code
- GBX
- 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 description
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Code information (models, lots, serial numbers)
Lot Number 10119247; UDI: (01)00827002106437(17)921110(10)10119247
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Cook G10643Cook Incorporated · CATHETER, IRRIGATION1 recall3 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 85187).
- Z-1566-2020 · TerminatedSpectrum Central Venous Catheter Tray, Irrigation Catheter, Reference Part Number C-UDLMY-401 J-ABRM-HC-IHl-FST, Order Number G48053
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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