Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 7,395 saline flush syringes used in POWERWAND kits 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 involves a medical device with compromised sterility, which poses a risk of infection (harm) to patients, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Access Scientific LLC is recalling 7,395 units of BD PosiFlush SF Saline Flush Syringe 10 mL used in the POWERWAND XL 4Fr 8cm Quick Kit. The recall is due to holes in the packaging that compromised the sterility of the syringes.
The affected products are identified by reference/UDI 94104/10859821006169 and specific lot numbers: 257837, 259820, 261063, 261317, 262161, 263001, 263648, 264816, 265133, 267194, 267195, 267718, 269001, 269005, 269713, 270780, and 270779. These 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.
The syringes are used to gain access to the vascular system to sample blood and administer fluids intravenously. They may also be used for power injection of contrast media. Consumers and healthcare providers 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 8cm Quick Kit. REF/UDI / 94104/10859821006169 - 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 med
- Manufacturer
- Access Scientific LLC
- Category
- Medical Device — Syringes
- Affected units
- 7,395
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 (17)
- LOTS: 257837
- 259820
- 261063
- 261317
- 262161
- 263001
- 263648
- 264816
- 265133
- 267194
- 267195
- 267718
- 269001
- 269005
- 269713
- 270780
- 270779
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
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
- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
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