Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes because some packages may have open seals, potentially compromising 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 (sterile medical device) where injury has not yet been reported, fitting the criteria for a High severity score.
Plain-English summary
Bard Access Systems is recalling specific units of BD PosiFlush SF Saline Flush Syringe 10 mL. The recall is due to a defect where some unit packages may exhibit open seals, which could impact the product's sterility. The affected syringes are included in various device kits, including SafeStep Port Access Kits, MiniLoc Port Access Kits, and PowerLoc Max Port Access Kits.
The recall covers 135,284 units that were distributed nationwide in the United States. The syringes are used to pre-flush catheters prior to placement and to verify patency post-placement. The source text does not report any illnesses or injuries associated with this defect.
Healthcare providers and consumers should check their inventory for the specific lot numbers and product codes listed in the official recall notice. If the product is found, it should be removed from use and returned to the manufacturer or disposed of according to local regulations.
The recalled product
- Product
- BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Port Access Kit 22G x 0.75in , SafeStep Port Access Kit 22G x 0.75in with Y-Site, SafeStep Port Access Kit 22G x 1 in , SafeStep Port Access Kit 20G x 0.75in , SafeStep Port Access Kit 20G
- Manufacturer
- Bard Access Systems
- Category
- Medical Device — Syringes
- Hazard
- Affected units
- 135,284
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: REXE0073
- REXD0494
- REYF0446
- REXE0074
- REXE0090
- REYE1239
- REXD1915
- REXD2151
- REXD2152
- REYE1275
- REYF0305
- REXD2142
- REYE1697
- REXE0082
- REYE1240
- REYE0972
- REXE0083
- REXE0072
- REXE0095
- REYE1276
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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- ModerateBard Access Systems Recalls PowerPICC Catheter Marketing Brochures
FDA (Devices) · 2015-09-30
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