Churchill Medical Recalls Vygon 14 Microbore Extension Sets
Churchill Medical Systems is recalling 13,100 Vygon 14 Microbore Extension Sets because the tubing may disconnect from the male luers.
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 medical device defect (tubing disconnection) that poses a risk of harm to patients, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Churchill Medical Systems, Inc. is recalling 13,100 units of the Vygon 14 Microbore Extension Set with Bionector, model CMS-814-1. These 14-inch extension sets are used to administer intravenous (IV) fluids. The recall is due to a defect where the microbore tubing may disconnect from the male luers on the extension sets.
The affected products were distributed nationwide in the United States, including the states of New York, Minnesota, New Jersey, Pennsylvania, Florida, Maryland, and Virginia. The recall covers units with the following lot codes: 1203117, 1206030, 1212111, 1304133, and 130516.
Healthcare providers and consumers should stop using the affected extension sets immediately. Users should check their inventory for the specific model number and lot codes listed above. If you have questions about this recall, contact Churchill Medical Systems, Inc.
The recalled product
- Product
- Vygon 14 Microbore Extension Set with Bionector, CMS-814-1. The CMS-814-1 is a 14 inch extension set used to administer IV fluids.
- Manufacturer
- Churchill Medical Systems, Inc.
- Hazard
- Affected units
- 13,100
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 (5)
- 1203117
- 1206030
- 1212111
- 1304133
- 130516
Distribution
Part of a larger recall action
This product is one of 2 recalled by Churchill Medical Systems, 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.
See all 2 products in this recall →Related recalls
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