Cook Inc. Recalls Pericardiocentesis Catheter Trays Due to Small Distal Hole
Cook Inc. is recalling two Pericardiocentesis Catheter Trays because the catheter distal end hole may be too small. The affected units were distributed domestically and internationally.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a medical device defect that poses a risk of harm, but the source text does not report any specific injuries or illnesses, placing it in the 'High' severity category per the rubric.
Plain-English summary
Cook Inc. is recalling two units of the Pericardiocentesis Catheter Tray, model RPN C-PCSY-850-LHSC-061096, Order # G10030. The recall is due to a manufacturing defect where the catheter distal end hole may be too small. The affected product is identified by Lot Number NS7639280.
The affected units were distributed domestically in Ohio and internationally to Canada, Spain, Italy, Belgium, Germany, the United Arab Emirates, Greece, Switzerland, Oman, Monaco, Saudi Arabia, Australia, Hong Kong, India, and Korea. The U.S. Food and Drug Administration has classified this recall as Class II.
Healthcare providers and facilities should stop using the affected product and contact Cook Inc. for further instructions. Consumers should not use the product if they have it in their possession.
The recalled product
- Product
- Pericardiocentesis Catheter Tray, RPN C-PCSY-850-LHSC-061096, Order # G10030
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheters
- Affected units
- 2
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 (1)
- Lot Number NS7639280
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 4 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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