BD Posiflush Pre-Filled Normal Saline Syringes Recalled Due to Labeling Mix-up
Becton Dickinson is recalling BD Posiflush Pre-Filled Normal Saline Syringes because a limited number of experimental units were mixed with standard stock.
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 3/5 (High).
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 involves a risk-of-harm product (medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Becton Dickinson & Company is recalling BD Posiflush Pre-Filled Normal Saline Syringes, Catalog Number 306547. The recall involves 1,632,000 units distributed in the United States and Canada. The specific lot number is 9142881 and the UDI is 50382903065474.
The recall was initiated because a limited number of syringes labeled "Posiflush Experimental Product" and "Not for Human Use" were mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes. This labeling discrepancy poses a risk of the experimental product being used for human patients.
Healthcare facilities and consumers should check their inventory for syringes with Lot Number 9142881. If the product is found, it should be removed from use and returned to the distributor or manufacturer according to the recall instructions.
The recalled product
- Product
- BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306547
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 1,632,000
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: 9142881 UDI: 50382903065474
Distribution
Distributed nationwide across the United States.
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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