RegWardenFDA facility compliance records
Recall

Class II — C.R. Bard, Inc.

Recalling firmC. R. Bard, Inc.
Registered facilityView this company's 19 registered facilities → (openFDA recall records do not name a specific facility)
ClassificationClass II
StatusTerminated
ReasonBMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
ProductBard(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 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) conne…
Quantity23400 units
DistributionUS Nationwide Distribution
Initiated2018-02-27
Classified2018-04-10
Terminated2019-07-11
Recall numberZ-1355-2018
InitiationVoluntary: Firm initiated

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Class II recall — C.R. Bard, Inc. (Z-1355-2018).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/79507/

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