Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling 16,410 units of BD PosiFlush Saline Flush Syringes included in various device kits because open seals may impact 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 medical device where open seals could impact sterility, posing a risk of harm (infection) without reported illnesses or injuries, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Bard Access Systems is recalling 16,410 units of BD PosiFlush SF Saline Flush Syringe 10 mL. These syringes are included in specific configurations of PICC kits, Port Access kits (PAK), PowerGlide kits, Midline kits, and Convenience kits. The recall is due to some unit packages exhibiting open seals, which could impact product sterility.
The affected products were distributed nationwide in the United States. The recall involves specific lot numbers and product codes, including lots such as REYE1714, REYE1713, and REXD1617, and product codes such as 2651910 and 2652010. The syringes are used to pre-flush the catheter prior to placement and may also be used to verify patency post-placement.
Healthcare providers and consumers should check their inventory for the affected lot numbers and product codes. If the product is found, it should be removed from use and returned to Bard Access Systems or the distributor.
The recalled product
- Product
- BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Port Access Kit 19G x 1 in, PowerLoc Port Access Kit 20G x 1 in, , , PowerLoc Port Access Kit 20G x 1.5in, PowerLoc Port Access Kit 20G x 0.75in, , , PowerLoc Port Access Kit 22G x 1 in, Power
- Manufacturer
- Bard Access Systems
- Hazard
- Affected units
- 16,410
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: REYE1714
- REYE1713
- REXD1617
- REXE0089
- REXE0077
- REYE1233
- REXE0085
- REXE0971
- REYE1709
- REYE1579
- REXD2157
- REYE1269
- REXD1932
- REXE0826
- REXE0086
- REXD2155
- REXD2156
- REXE0697. Product codes: 2651910
- 2652010
- 2652015
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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