Recall Z-1357-2018— C.R. Bard, Inc.

Class II FDA medical device recall by C.R. Bard, Inc., initiated 2018-02-27, terminated 2019-07-11. FDA's recall record names no specific 510(k) clearance for this event. Product: Bard(R) Premature Infant Feeding tube, ENFit(TM), REF EN0036430 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 feeding, lavage fluid and medications Feeding Tubes with the ENFit(TM) Connector are made of a smooth plastic with a two-eyed tube used for nasogastric feeding of neonates, infants and adults as well as diagnostic and therapeutic aspiration. These products are sold single-use, sterile. The Feeding Tube with the ENFit(TM) connector provides a way to reduce the risk of enteral device misconnections. The ENFit(TM) connector: Addresses patient side connections between feeding tubes, administration sets, medication, flush and bolus feeding syringes, and other enteral devices. Does not allow connectivity with any other connector for any other clinical use.. Reason: BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector..

Recalling firm

C.R. Bard, Inc.

Classification

Class II

Status

Terminated

Initiated

2018-02-27

Terminated

2019-07-11

Firm location

Covington, GA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.