Recall Z-0798-2024— C.R. Bard Inc

Name: FDA recall Z-0798-2024
Creator: U.S. Food and Drug Administration
Published: 2023-12-20

Class II · Ongoing

Class II FDA medical device recall by C.R. Bard Inc, initiated 2023-12-20. It names one FDA 510(k) clearance: K960176. Product: Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140. 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..

Recalling firm: C.R. Bard Inc
Classification: Class II
Status: Ongoing
Initiated: 2023-12-20
Firm location: Covington, GA, United States

510(k) clearances named in this recall

1 on FDA's record

K960176 — DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTERC.R. Bard, Inc.·cleared 1996-07-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Bard¿ Nasogastric Sump Tube with PreVent¿ Anti-Reflux Filter with ENFit, 14Fr., 48in Long, REF EN0046140

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.