Class 2 Device Recall Bard(R) Adult/Pediatric Feeding Tube

• Date Initiated by Firm: February 27, 2018
• Create Date: April 11, 2018
• Recall Status: Terminated on July 11, 2019
• Recall Number: Z-1356-2018
• Recall Event ID: 79507
• Product Classification: Tube, feeding - Product Code FPD
• 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.
• Code Information: Lot Numbers: NGAY4533, NGAX3534, NGARX206
• Recalling Firm/ Manufacturer: C.R. Bard, Inc.; 8195 Industrial Blvd NE; Covington GA 30014-1497
• For Additional Information Contact: 770-784-6120
• Manufacturer 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 Determined 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.