CLASS II Device recall · Reported 1 Apr 2020 · FDA Enforcement Report

Pericardiocentesis Set, Irrigation Catheter, Reference recalled by Cook

Cook is recalling Pericardiocentesis Set, Irrigation Catheter, Reference, distributed in 7 states. The recall was initiated on 6 Mar 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot Number 10119247; UDI: (01)00827002106437(17)921110(10)10119247

Quantity recalled25

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1565-2020
FDA event ID: 85187
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 6 Mar 2020
FDA classified: 24 Mar 2020
Reported: 1 Apr 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Heart & Vascular Devices

Timeline

6 Mar 2020	Recall initiated by company
24 Mar 2020	Classified by FDA	+18 days
1 Apr 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The printed expiration dates are incorrect.

Product as listed by the FDA

Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643

Where it was distributed

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.

Colorado Delaware Maryland Minnesota North Carolina Nevada West Virginia

Questions about this recall

Why was it recalled?

The printed expiration dates are incorrect.

Which lots are affected?

Lot Number 10119247; UDI: (01)00827002106437(17)921110(10)10119247

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 85187

This product is part of a recall event; the main page for the event is Spectrum Central Venous Catheter Tray, Irrigation Catheter recalled.

Reported	Class	Recall	Company	Reason	Where
1 Apr 2020	CLASS II	Spectrum Central Venous Catheter Tray, Irrigation Catheter recalled	Cook	Other	7 states

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