Access Scientific Recalls BD PosiFlush Saline Syringes Due to Packaging Holes
Access Scientific LLC is recalling 6,066 units of BD PosiFlush SF Saline Flush Syringes because holes in the packaging compromised 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 is classified as FDA Class II, and the hazard involves compromised sterility in a medical device used for vascular access, which presents a risk of harm even without reported injuries.
Plain-English summary
Access Scientific LLC is recalling 6,066 units of BD PosiFlush SF Saline Flush Syringe 10 mL used in the POWERWAND XL 4Fr 10cm Quick Kit. The recall is due to holes in the packaging that compromised the sterility of the syringes.
The affected products are identified by REF/UDI 94105/10859821006190 and include lots 257862, 260252, 261065, 262162, 263385, 264339, 267088, 268940, 268942, 269086, 269334, 269340, 270250, and 270777. These syringes are used to gain access to the vascular system to sample blood and administer fluids intravenously, and may be used for power injection of contrast media.
The products were distributed nationwide in the United States, including in the states of AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, ME, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, OR, PA, SC, SD, TN, TX, and UT. Healthcare facilities should stop using the affected syringes and contact Access Scientific LLC for further instructions.
The recalled product
- Product
- BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Quick Kit. REF/UDI / 94105/10859821006190 - Product Usage: is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may be used for power injection of contrast me
- Manufacturer
- Access Scientific LLC
- Category
- Medical Device — Syringes
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 (14)
- LOTS: 257862
- 260252
- 261065
- 262162
- 263385
- 264339
- 267088
- 268940
- 268942
- 269086
- 269334
- 269340
- 270250
- 270777
Distribution
Part of a larger recall action
This product is one of 12 recalled by Access Scientific LLC 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 12 products in this recall →Related recalls
Same manufacturer · Access Scientific LLC
See all →- LowAccess Scientific Recalls Mislabeled Powerwand XL Maximum Barrier Kits
FDA (Devices) · 2020-07-22
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
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- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Defects
FDA (Devices) · 2020-05-20
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
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