Z-1356-2018Class II

Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420

Name: Z-1356-2018 Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420
Creator: C.R. Bard, Inc.
Published: 2018-02-27
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2018-02-27 / Terminated

FDA source

C.R. Bard, Inc. began a recall of Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 Product Usage: BARD(R) Nasogastric Sump Tubes with ENFit(TM) connector are intended to be used... on 2018-02-27. FDA classified it as Class II and gives the reason as "BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1356-2018
Classification: Class II
Status: Terminated
Initiated: 2018-02-27
Posted: 2018-04-11
Terminated: 2019-07-11
Recalling firm: C.R. Bard Inc
Product: Bard(R) Adult/Pediatric Feeding Tube, ENFit(TM), REF EN0036420 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.
Product code: FPD Tube, Feeding
Reason for recall: BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
FDA root cause: Finished device change control
Action: The firm initiate their recall by letter on 02/27/2018 by letter. The recall letter stated: "Action required: " Immediately examine your inventory and quarantine product subject to this recall. Please refer to the sample product labeling on Attachment 1 to help you locate the product. Do not use or further distribute any affected product. " Please complete and return the accompanying Recall & Effectiveness Check Form attached to this letter regardless of whether or not you have any of the affected product. Additional instructions for product return are contained on the form. Upon receipt of the form indicating there is product to return, the BMD Recall Coordinator will issue you a return authorization number for return of the affected product. " If you have further distributed any units from the affected lots, please identify your customers and notify them at once of this product recall by forwarding a copy of this letter. Your notification should include a copy of this letter and the accompanying enclosures. This recall should be carried out to the user level."
Quantity in commerce: 3200 units
Distribution: US Nationwide Distribution
Product codes and lots: Lot Numbers: NGAY4533, NGAX3534, NGARX206

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1356-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1354-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1355-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1356-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10
Z-1357-2018	Class II	Terminated	Voluntary: Firm initiated	2018-04-18	2018-04-10

Product code FPD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)