FDA Medical Device Recalls (openFDA)
C.R. Bard Inc: Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000
- Recall number
- Z-0795-2024
- Recalling firm
- C.R. Bard Inc
- Product
- Bard PreVent Anti-Reflux Filter with ENFit, REF EN0046000
- Status
- Open, Classified
- Initiated
- 2023-12-20
- Posted
- 2024-01-25
- Terminated
- not on file
- Reason
- 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
- 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
- 39430 units
- Distribution
- US
- Lot, serial or model codes
- 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
- 510(k) numbers
- ["K960176"]
- PMA numbers
- not on file
- Product code
- FEG
- Firm FEI
- 1018233
- Firm city
- Covington
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28