BD Posiflush Syringes Recalled Due to Experimental Product Mix-Up
Becton Dickinson is recalling BD Posiflush syringes because a limited number of experimental units were mixed with standard products.
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 High severity criteria.
Plain-English summary
Becton Dickinson & Company is recalling BD Posiflush Pre-Filled Normal Saline Syringes, Catalog Number 306575. The recall involves 967,680 units distributed in the United States and Canada.
The recall was initiated because a limited number of syringes labeled "Posiflush Experimental Product" and "Not for Human Use" were found mixed with standard BD Posiflush Pre-Filled Normal Saline Syringes. The affected lot number is 9175971, and the UDI is 50382903065757.
Healthcare facilities and consumers should stop using the affected syringes and contact Becton Dickinson for further instructions.
The recalled product
- Product
- BD Posiflush Pre-Filled Normal Saline Syringes Catalog Number: 306575 (Canada only)
- Manufacturer
- Becton Dickinson & Company
- Category
- Medical Device — Syringes
- Affected units
- 967,680
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: 9175971 UDI: 50382903065757
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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