C.R. Bard Nasogastric Sump Tubes recalled for inadequate drainage and suction
C.R. Bard is recalling Bard Nasogastric Sump Tubes with ENFit connectors due to user reports of inadequate suction and drainage. The recall affects 16,564 units distributed in the United States.
What this means for you
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 a Class II medical device recall with reported inadequate or reduced suction, decompression, and drainage. Per the rubric, the score is High (3) because it is a risk-of-harm product where injury has not yet been reported.
Plain-English summary
C.R. Bard Inc is recalling Bard Nasogastric Sump Tubes with ENFit connectors (16Fr., 48 inches long, model EN0042160). The recall affects 16,564 units distributed in the United States. The affected product is identified by UDI/DI 00801741113802 and the following lot numbers: NGDU4226, NGEQ3059, NGER3655, NGEY1508, NGEY2686, NGEZ2776, NGFP0405, NGFS4370, NGFT5975, NGFU1797, NGFV1674, NGFV3527, NGFW1855, NGFX2682, NGFX5610, and NGGV0790.
C.R. Bard has received user complaints reporting that during use of these tubes, inadequate or reduced suction, decompression, and drainage occurred. Nasogastric tubes are used to deliver nutrition, medications, and to remove gastric contents.
Healthcare facilities and patients using these tubes should check the lot numbers to determine if their products are affected. If affected, users should stop using the recalled products and contact C.R. Bard Inc for replacement units or further guidance.
The recalled product
- Product
- Bard¿ Nasogastric Sump Tube with ENFit, 16Fr., 48in Long, REF EN0042160
- Manufacturer
- C.R. Bard Inc
- Category
- Medical Device
- Affected units
- 16,564
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 (17)
- UDI/DI 00801741113802
- Lot/Serial Numbers: NGDU4226
- NGEQ3059
- NGER3655
- NGEY1508
- NGEY2686
- NGEZ2776
- NGFP0405
- NGFS4370
- NGFT5975
- NGFU1797
- NGFV1674
- NGFV3527
- NGFW1855
- NGFX2682
- NGFX5610
- NGGV0790
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.
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