Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0806-2024Class II

Bard Suction Connector with ENFit, REF EN0066000

C.R. Bard Inc / initiated 2023-12-20 / Open, Classified

C.R. Bard Inc began a recall of Bard Suction Connector with ENFit, REF EN0066000 on . FDA classified it as Class II and gives the reason as "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". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-0806-2024
Classification
Class II
Status
Open, Classified
Initiated
Posted
Recalling firm
C.R. Bard Inc
Product
Bard Suction Connector with ENFit, REF EN0066000
Product code
KNT Tubes, Gastrointestinal (And Accessories)
Reason for recall
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.
FDA root cause
Under Investigation by firm
Action
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.
Quantity in commerce
133610 units
Distribution
US
Product codes and lots
UDI/DI 00801741128707, Lot/Serial Numbers: NGFS2792, NGFS4371, NGFV1647, NGFV1669, NGGN1988, NGGN2930, NGGN3517, NGGP0451, NGGP1098, NGGV0739, NGGV2722, NGGV5069, NGGW4456, NGGX3169, NGGZ0564, NGGZ1915, NGHP2225, NGHQ2201, NGHR0090, NGHS1005, NGHS1006, NGHS2421, NGHS3331, NGHU0845, NGHU1555, NGHV0467, NGHV2758, NGHW3025, NGHX1021, NGHX3269

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0806-2024
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0790-2024Class IIOngoingVoluntary: Firm initiated
Z-0791-2024Class IIOngoingVoluntary: Firm initiated
Z-0792-2024Class IIOngoingVoluntary: Firm initiated
Z-0793-2024Class IIOngoingVoluntary: Firm initiated
Z-0794-2024Class IIOngoingVoluntary: Firm initiated
Z-0795-2024Class IIOngoingVoluntary: Firm initiated
Z-0796-2024Class IIOngoingVoluntary: Firm initiated
Z-0797-2024Class IIOngoingVoluntary: Firm initiated
Z-0798-2024Class IIOngoingVoluntary: Firm initiated
Z-0799-2024Class IIOngoingVoluntary: Firm initiated
Z-0800-2024Class IIOngoingVoluntary: Firm initiated
Z-0801-2024Class IIOngoingVoluntary: Firm initiated
Z-0802-2024Class IIOngoingVoluntary: Firm initiated
Z-0803-2024Class IIOngoingVoluntary: Firm initiated
Z-0804-2024Class IIOngoingVoluntary: Firm initiated
Z-0805-2024Class IIOngoingVoluntary: Firm initiated
Z-0806-2024Class IIOngoingVoluntary: Firm initiated