Becton Dickinson Recalls Gravity IV Sets Due to Kinked Tubing
Becton Dickinson is recalling specific lots of Gravity IV Sets with 3-port Closed Stopcock Manifolds due to a confirmed complaint trend for kinked tubing.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The source text cites a 'confirmed complaint trend' for kinked tubing but does not report any hospitalizations, serious injuries, or deaths. Per the rubric, this falls under moderate severity as it is a defect without reported severe harm.
Plain-English summary
Becton Dickinson & Company has initiated a recall of Gravity IV Sets with 3-port Closed Stopcock Manifold Model CM42500E-07. The recall is being conducted due to a confirmed complaint trend regarding kinked tubing on the specified lots of the product.
The affected product includes 21,220 total cases of 20 units. The specific lot codes involved are 18105828, 18105830, 18105857, and 18105858. These products were distributed to accounts in Alabama, California, the District of Columbia, Florida, Louisiana, Maryland, Nebraska, Tennessee, Virginia, and Washington.
Healthcare facilities and distributors should check their inventory for these specific lot codes and stop using the affected products. Becton Dickinson is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Gravity IV Set with 3-port Closed Stopcock Manifold Model CM42500E-07
- Manufacturer
- Becton Dickinson & Company
- Hazard
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 (1)
- 18105828 18105830 18105857 18105858
Distribution
Part of a larger recall action
This product is one of 2 recalled by Becton Dickinson & Company 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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