Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in various catheter kits because open seals may compromise product sterility.
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 involves a risk-of-harm product (sterility compromise) where injury has not yet been reported, which aligns with the 'High' severity criteria for theoretical hazards without confirmed illness.
Plain-English summary
Bard Access Systems is recalling specific unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL. These syringes are included in several Bard device kits, including PICC kits, Port Access kits, PowerGlide kits, Midline kits, and Convenience kits.
The recall is being issued because some unit packages may exhibit open seals. This defect could impact the sterility of the product. The source text does not specify the number of affected units, specific lot numbers, or the geographic distribution of the recalled items.
Healthcare facilities and consumers should check their inventory for these specific syringes within the affected kits. If open seals are observed, the products should be removed from use. The source text does not provide specific instructions for disposal or return, nor does it report any illnesses or injuries associated with the defect.
The recalled product
- Product
- BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly Midline 3F Full Tray (Single-Lumen) (with Microintroducer), Bard Poly Midline 3F Maximal Barrier Tray (Single-Lumen), Bard Poly Midline 4F Maximal Barrier Tray (Single-Lumen) (with Microintro
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Catheter Kits
- Hazard
- Affected units
- 134,554
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 (20)
- Lot Numbers: REXE1224
- REYD1858
- REXE0422
- REXE0501
- REYD0765
- REYE1330
- REYE1453
- REXE0428
- REXE0469
- 13GB3687
- REXD1150
- 13HB2925
- REYD1851
- REXD1127
- REYD1730
- REXE0436
- REXD1121
- REXE0504
- REXD1122
- REXD1480
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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