Bard Access Systems Recalls BD PosiFlush Saline Syringes Due to Open Seals
Bard Access Systems is recalling BD PosiFlush Saline Flush Syringes included in certain 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 medical device where a defect (open seals) could impact sterility, posing a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
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 device kits, including PowerGlide Midline Catheter Full Kits, Maximal Barrier Trays, and other configurations such as PICC kits, Port Access kits, and Convenience kits. The syringes are used to pre-flush catheters prior to placement and to verify patency post-placement.
The recall is being issued because some unit packages may exhibit open seals, which could impact the sterility of the product. The affected lots are REYE1308, REYE2224, REYD0054, REYE2225, REYE1434, and REYE2226, with product codes M120081, M120081D, M120101, and M118081. A total of 4,375 units were distributed nationwide in the United States.
Healthcare providers and facilities should check their inventory for these specific lot numbers and product codes. If the syringes are found, they should be removed from use and returned to Bard Access Systems according to their instructions. Patients who have already received these syringes should contact their healthcare provider if they have concerns regarding the sterility of the device.
The recalled product
- Product
- BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide Midline Catheter Full Kit (20G) (8cm), PowerGlide Midline Catheter Maximal Barrier Tray (20G) (8cm), PowerGlide Midline Catheter Full Kit (20G) (10cm), The syringe is used to pre-flush t
- Manufacturer
- Bard Access Systems
- Affected units
- 4,375
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 (9)
- Lot Numbers: REYE1308
- REYE2224
- REYD0054
- REYE2225
- REYE1434
- REYE2226 Product codes: M120081
- M120081D
- M120101
- M118081
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.
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