Becton Dickinson Recalls CareFusion Safe-T-Centesis Catheter Drainage Trays
Becton Dickinson is recalling 900 units of CareFusion Safe-T-Centesis Catheter Drainage Trays because the 8 Fr catheter was manufactured with a 6.9 Fr needle instead of the correct 8 Fr needle.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The source text does not report any injuries, illnesses, or fatalities, and the defect is a manufacturing specification error rather than a high-risk pathogen or structural failure.
Plain-English summary
Becton Dickinson & Company is recalling 900 units of CareFusion Safe-T-Centesis Catheter Drainage Trays, sterile, for single use only. The specific product affected is identified by Catalog Number PIG1280T and Lot Number 0001304986.
The recall was initiated because the 8 Fr catheter was manufactured with a 6.9 Fr needle instead of the correct 8 Fr needle. This manufacturing error results in a component that does not match the specified product description.
The affected units were distributed domestically to Alabama, Colorado, Illinois, Massachusetts, Missouri, Oklahoma, Rhode Island, Virginia, and Wisconsin. Healthcare providers and facilities should stop using the affected product and contact Becton Dickinson for further instructions or a return.
The recalled product
- Product
- CareFusion Safe-T-Centesis Catheter Drainage Tray, Sterile, For Single Use Only, Rx only, Catalog Number PIG1280T, UDI Number 01)10885403108402(17) 210930(10)0001304986
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 900
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)
- Lot Number: 0001304986
Distribution
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