Bard PreVent Anti-Reflux Filter with ENFit Recall for Reduced Suction
C.R. Bard is recalling Bard PreVent Anti-Reflux Filters with ENFit connectors due to user reports of inadequate or reduced suction, decompression, and drainage during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II medical device recall with no reported hospitalizations, injuries, or deaths. The functional failure affecting suction and drainage represents a risk-of-harm scenario, but without reported adverse events in the source material.
Plain-English summary
C.R. Bard Inc is recalling the Bard PreVent Anti-Reflux Filter with ENFit connectors (REF EN0046000, UDI/DI 00801741113765). A total of 39,430 units distributed in the United States have been identified in this Class II recall.
The recall was initiated due to user complaints reporting inadequate or reduced suction, decompression, and drainage during use of the device. These functional failures could compromise the filter's intended performance.
The affected lot/serial numbers include: NGEV2409, NGEY1492, NGEY2717, NGEZ0908, NGEZ1657, NGEZ2692, NGFQ4105, NGFR1077, NGFR2312, NGFR3259, NGFS1627, NGFS4431, NGFT5468, NGFU1877, NGFU3837, NGFV1652, NGFV3513, NGFW1856, NGFX0167, NGFX2672, NGFX5611, NGGP3169, NGGT3611. Healthcare providers should verify their inventory against these lot numbers and contact C.R. Bard for guidance.
The recalled product
- Product
- Bard¿ PreVent¿ Anti-Reflux Filter with ENFit, REF EN0046000
- Manufacturer
- C.R. Bard Inc
- Affected units
- 39,430
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 17 recalled by C.R. Bard Inc under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 17 products in this recall →Related recalls
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