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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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.
- Hazard
- 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
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.
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