The Recall Desk
LowFDA (Devices)·Z-1565-2020·Announced 2020-04-01

Cook Inc. Recalls Pericardiocentesis Sets Due to Incorrect Expiration Dates

Cook Inc. is recalling 25 Pericardiocentesis Sets because the printed expiration dates are incorrect. The products were distributed to seven US states and Canada.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is for a documentation issue (incorrect expiration dates) with no reported injuries or illnesses, fitting the 'Low' severity criteria for packaging or documentation problems.

Plain-English summary

Cook Inc. is recalling 25 units of the Pericardiocentesis Set, Irrigation Catheter (Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643). The recall was initiated because the printed expiration dates on the products are incorrect.

The affected products, identified by Lot Number 10119247, were distributed to healthcare facilities in Colorado, Delaware, Maryland, Minnesota, North Carolina, Nevada, and West Virginia, as well as to Canada.

Healthcare facilities should stop using the affected products and contact Cook Inc. for further instructions. Consumers are not expected to have these products in their homes.

The recalled product

Product
Pericardiocentesis Set, Irrigation Catheter, Reference Part Number C-PCS-700-TORONT0-042997, Order Number G10643
Manufacturer
Cook Inc.
Affected units
25

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 (2)

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

Distribution

Distributed in 7 states:

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 →