Cook Inc. Recalls Pericardiocentesis Catheter Sets Due to Small Distal Hole
Cook Inc. is recalling 83 Pericardiocentesis Catheter Sets 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 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 the defect in a medical device used for pericardiocentesis presents a risk of harm where injury has not yet been reported.
Plain-English summary
Cook Inc. is recalling 83 Pericardiocentesis Catheter Sets, model RPN C-PCS-850, Order # G03282. The recall is due to a manufacturing defect where the catheter distal end hole may be too small.
The affected lots are 7716007, 7703324, NS7703501, NS7703502, NS7703503, NS7704718, NS7704722, NS7704727, and NS7704728. These products 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.
Healthcare providers and consumers should stop using these specific kits and contact Cook Inc. for further instructions.
The recalled product
- Product
- Pericardiocentesis Catheter Set, RPN C-PCS-850, Order # G03282
- Manufacturer
- Cook Inc.
- Category
- Medical Device — Catheter
- Hazard
- Affected units
- 83
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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