Z-1356-2018 Class II Terminated
FDA device recall Z-1356-2018 was initiated by C.R. Bard, Inc. on Feb 27, 2018 and is designated Class II. Reason for recall: BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector. The recall status is terminated (terminated Jul 11, 2019). Affected quantity: 3200 units.
Recall Details
- Product Type
- Devices
- Report Date
- Apr 18, 2018
- Initiation Date
- Feb 27, 2018
- Termination Date
- Jul 11, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3200 units
Product Description
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.
Reason for Recall
BMD has identified that the product code/lot number combination identified above may have ineffectively fused tubing and ENFit(TM) connector.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot Numbers: NGAY4533, NGAX3534, NGARX206
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1356-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026