Bard Infant Feeding Tube Recalled for Ineffective Connector Fusion
C.R. Bard is recalling 23,400 infant feeding tubes because the tubing and connector may not be effectively fused.
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 that could lead to device failure or misconnection, representing a risk of harm where injury has not yet been reported, consistent with the High severity criteria.
Plain-English summary
C.R. Bard, Inc. is recalling 23,400 units of Bard Infant Feeding Tubes, ENFit, REF EN0036410. The affected lots are NGARX207 and NGAX3462. These products were distributed nationwide in the United States.
The recall was initiated because the U.S. Food and Drug Administration identified that the product code and lot number combination may have ineffectively fused tubing and ENFit connector. The ENFit connector is designed to reduce the risk of enteral device misconnections by only allowing connectivity with specific compatible devices.
These tubes are intended for the decompression of the stomach and short-term administration of tube feeding, lavage fluid, and medications for neonates, infants, and adults. The products are sold as single-use, sterile items. Consumers and healthcare providers should stop using the affected units and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Bard(R) Infant Feeding Tube, ENFit(TM), REF EN0036410 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used for: Decompression of stomach by suction or aspiration of gastric contents Short-term administration of term tube…
- Manufacturer
- C.R. Bard, Inc.
- Affected units
- 23,400
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 (2)
- Lot numbers: NGARX207
- NGAX3462
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by C.R. Bard, 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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