Bard Access Systems Recalls BD PosiFlush Saline Flush Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain device kits because open seals may compromise product sterility.
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 the hazard involves potential loss of sterility without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Bard Access Systems is recalling specific units of BD PosiFlush SF Saline Flush Syringe 10 mL. These syringes are included in various Bard device kits, including Groshong Midline Bard MYPICC Kit 4F (Single-Lumen), PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits. The syringes are used to pre-flush catheters prior to placement and to verify patency post-placement.
The recall is due to a potential defect where some unit packages may exhibit open seals. This condition could impact the sterility of the product. The affected lot number is 13FB8860, and the product code is CK000069. The recall involves 48 units that were distributed nationwide in the United States.
Healthcare providers and facilities should check their inventory for the specific lot and product codes listed. If the affected syringes are found, they should be removed from use and returned to Bard Access Systems according to the recall instructions.
The recalled product
- Product
- BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Midline Bard MYPICC Kit 4F (Single-Lumen) The syringe is used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 48
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 Numbers: 13FB8860 Product codes: CK000069
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Bard Access Systems 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.
See all 5 products in this recall →Related recalls
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