Becton Dickinson Recalls 13 Fr Trialysis Catheters Due to Packaging Error
Becton Dickinson is recalling 75 units of 13 Fr Trialysis Catheters because a portion of the lot was incorrectly packaged with a 12.5cm catheter instead of a 15cm catheter.
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 and involves a packaging error (wrong length) without reported injuries or illnesses, fitting the criteria for moderate severity.
Plain-English summary
Becton Dickinson & Company is recalling 75 units of the 13 Fr. Trialysis Catheter with Alphacurve (Catalog No. 5653150, UDI: 00801741066023). The recall is due to a packaging error where a portion of the lot was incorrectly packaged with a 12.5cm catheter instead of the intended 15cm catheter.
The affected products were distributed to healthcare facilities in Arkansas, Florida, Illinois, New Jersey, Texas, and Wisconsin. The recall number is Z-0285-2020.
Healthcare facilities should stop using the affected catheters and contact Becton Dickinson for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- 13 Fr. Trialysis Catheter with Alphacurve. Catalog No. 5653150. UDI: 00801741066023 Power-Trialysis Short-Term Alphacurve Dialysis Catheter with a third internal umen for IV therapy, power injection of contrast media, and central venous pressure monitoring.
- Manufacturer
- Becton Dickinson & Company
- Hazard
- Affected units
- 75
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)
- REDR0440
Distribution
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