Becton Dickinson Recalls PCEA Administration Sets Due to Potential Leaks
Becton Dickinson is recalling PCEA Administration Sets because they may leak at the connection point. The recall covers 566,737 units distributed worldwide.
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: The recall is classified as FDA Class II, and the hazard involves a potential leak in a medical device used for drug administration, which poses a risk of harm even though no specific injuries are reported in the source text.
Plain-English summary
Becton Dickinson & Company is recalling PCEA Kit ASV Yellow Stripe Microbore administration sets, Catalog Number 10800177. The recall involves 566,737 units distributed in the United States, Canada, the United Arab Emirates, and Saudi Arabia. The affected batch numbers are 16127933, 17017602, 17055977, 17117153, 17125385, and 18015788.
The recall was initiated because the products have the potential to leak between the connection of the male luer lock and the yellow striped tubing. This defect could compromise the integrity of the administration set during use.
Healthcare facilities and consumers should check their inventory for the specific catalog and batch numbers listed above. If the product is found, it should be removed from use and returned to Becton Dickinson & Company according to the firm's instructions.
The recalled product
- Product
- PCEA Kit ASV Yellow Stripe Microbore, Catalog Number 10800177 Product Usage: PCEA Administration Set. Microbore tubing with Yellow Identification Stripe. Anti-siphon valve. Set cannot be used for gravity infusion 1. Connect PCA syringe to female luer on administration set.
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Infusion Sets
- Hazard
- Affected units
- 566,737
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)
- Batch numbers: 16127933 17017602 17055977 17117153 17125385 18015788
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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