Umbilical Vessel Catheter 5 French Single Lumen Packaging Defect Recall
Cardinal Health is recalling umbilical vessel catheters due to a packaging defect that may compromise sterility, risking infection in newborns if non-sterile products are used.
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 involves a Class II medical device where the hazard is a high-risk pathogen (infection) with potential for serious harm to a vulnerable population (neonates), but no illnesses or injuries have been reported. The source text states only the theoretical risk of infection if non-sterile product is used.
Plain-English summary
Cardinal Health 200, LLC is recalling Catalog No. 8888160341 Umbilical Vessel Catheter 5 French single lumen due to a packaging defect that may compromise the sterility of the product.
The defect affects 51,378 units distributed nationwide across multiple US states and internationally to Brazil, Canada, Chile, Colombia, Singapore, and South Africa. Affected lot numbers are: 2427700158, 2425600066, 2433000005, 2427700160, 2425600067, 2425600070, 2415100113, 2425600071, 2427700159, 2415100110, 2412100093, 2433000095, 2425600069, 2425600077, 2415100116, 2425600063, 2425600074, 2415100115, 2415100114, 2412100096, 2425600072, 2425600075, 2404400061, 2425600064, 2415100106, 2425600076, 2415100107, 2415100112, 2425600073, 2425600065, 2404400062, 2404400065, 2415100093, 2415100109, 2415100111, and 2433000094.
If a non-sterile catheter is used on a patient, it could lead to infection in neonates. Healthcare facilities should identify and quarantine affected units by lot number and consult the FDA or manufacturer for further guidance.
The recalled product
- Product
- Catalog No. 8888160341; Umbilical Vessel Catheter 5 French single lumen
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 51,378
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)
- UDI-DI (ea) 10192253040319
Distribution
Part of a larger recall action
This product is one of 6 recalled by Cardinal Health 200, LLC 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 6 products in this recall →Related recalls
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