Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 2,055 saline flush syringes because holes in the packaging compromised their sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with compromised sterility, which poses a risk of infection (risk-of-harm product), but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Access Scientific LLC is recalling 2,055 units of BD PosiFlush SF Saline Flush Syringe 10 mL used in the POWERWAND XL 4Fr 10cm Max Barrier Kit. The recall is due to holes in the packaging that compromised the sterility of the syringes.
The affected product is used to gain access to the vascular system to sample blood and administer fluids intravenously. It may also be used for power injection of contrast media. The recall covers lots 259532, 259909, 260326, 269087, 267012, 269119, and 269341.
The product was 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. Consumers and healthcare facilities should stop using the affected syringes and contact the manufacturer for instructions.
The recalled product
- Product
- BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Max Barrier Kit. REF/UDI / 94107/10859821006206 - 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…
- Manufacturer
- Access Scientific LLC
- Category
- Medical Device — Syringes
- Affected units
- 2,055
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 (7)
- LOTS:259532
- 259909
- 260326
- 269087
- 267012
- 269119
- 269341
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
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See all →- LowAccess Scientific Recalls Mislabeled Powerwand XL Maximum Barrier Kits
FDA (Devices) · 2020-07-22
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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 Holes
FDA (Devices) · 2020-05-20
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