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 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, which corresponds to a severity score of 4 (Severe) according to the rubric.
Plain-English summary
Cook Inc. is recalling two units of the Pericardiocentesis Catheter Tray, model RPN C-PCYS-850, Order # G03284. 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 NS7726043. The 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.
This is a Class II recall. Users should stop using the affected devices and contact Cook Inc. for further instructions.
The recalled product
- Product
- Pericardiocentesis Catheter Tray, RPN C-PCYS-850, Order # G03284
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheter
- Hazard
- 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 NS7726043
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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