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Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000 recallZ-0795-2024 · C.R. Bard Inc · initiated Dec 20, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from C.R. Bard Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number
Z-0795-2024
Status
Open, Classified
Initiated by the company
Dec 20, 2023
Posted by the FDA
Jan 25, 2024
Recalling firm
C.R. Bard Inc
Quantity
39430 units
Product code
FEG
FDA submissions
K960176
Distribution
US

Product description

Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000

Code information (models, lots, serial numbers)

UDI/DI 00801741113765, Lot/Serial Numbers: NGEV2409, NGEY1492, NGEY2717, NGEZ0908, NGEZ1657, NGEZ2692, NGFQ4105, NGFR1077, NGFR2312, NGFR3259, NGFS1627, NGFS4431, NGFT5468, NGFU1877, NGFU3837, NGFV1652, NGFV3513, NGFW1856, NGFX0167, NGFX2672, NGFX5611, NGGP3169, NGGT3611

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 93679).

Sources and updates

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