—#205290

Product

Bard Nasogastric Sump Tube and PreVent Anti-Reflux Filter and Lopez Valve with ENFit, 12Fr., 48in Long, REF EN0056120

FDA product code: FEG — Tube, Double Lumen For Intestinal Decompression And/Or Intubation
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K960176
Affected lot / code info: UDI/DI 00801741113840, Lot/Serial Numbers: NGDU4228, NGGR2707

Why it was recalled

BD (C.R. Bard) has received user complaints reporting that during use of BD Bard NG Sump Tubes with ENFit Connectors, inadequate or reduced suction, decompression, and drainage occurred.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

BD (C.R. Bard) issued an URGENT Medical Device Recall Notice to its consignees via FedEx and email. The notice explained the problem with the devices, potential risks, and the devices be removed, quarantined, and discarded. Disseminate the notice to all users within the facility. If you have purchased this product through a distributor, please contact this distributor to request appropriate credit or order alternate replacement product. Complete and return the attached Customer Response Form to the BD contact noted on the form confirming acknowledgement of the correction notification, whether or not you have any affected product, so that BD may confirm your receipt of this notification and provide credit or alternate product. In addition to the information above, Distributors were directed to take the following actions: Please discontinue distribution of all product codes in the table above, and immediately dispose of all affected product remaining in your possession in accordance with your local facility s process. 2. Identify all customers within your distribution network that purchased any affected product as defined in this notification. Provide a copy of the attached customer letter to all customers to advise them of this field action notification on BD s behalf. Attachment 2 3. Complete the attached Distributor Response Form and return to the BD contact noted on the form confirming acknowledgement of the recall notification, whether or not you have any of the impacted product, so that BD may acknowledge your receipt of this notification. 4. Indicate on the response form the quantity of product identified at your facility and confirm that this inventory was destroyed. Attachment 1 5. Please contact your BD representative if you require assistance with credits to be issued for discarded products or for replacement product options. You may also contact the number below for further assistance.

Recalling firm

Firm: C.R. Bard Inc
Address: 8195 Industrial Blvd Ne, Covington, Georgia 30014-1497

Distribution

Distribution pattern: US

Timeline

Recall initiated: 2023-12-20
Posted by FDA: 2024-01-25
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #205290. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.