Access Scientific Recalls Saline Flush Syringes Due to Packaging Holes
Access Scientific LLC is recalling 570 units of BD PosiFlush SF Saline Flush Syringes used in POWERWAND XL catheters 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 570 units of BD PosiFlush SF Saline Flush Syringes (10 mL) used in POWERWAND XL 4Fr 10cm Extended Dwell Catheters. The recall was initiated because holes in the packaging compromised the sterility of the syringes.
The affected products are identified by lot numbers 269939, 270552, and 270874, with REF/UDI 94108/00859821006773. These syringes are used to gain access to the vascular system to sample blood and administer fluids intravenously, including 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 and consumers should stop using the affected syringes and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 4Fr 10cm Extended Dwell Catheter. REF/UDI / 94108/00859821006773 - 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
- Manufacturer
- Access Scientific LLC
- Affected units
- 570
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 (3)
- LOTS:269939
- 270552
- 270874
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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- 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
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- HighAccess Scientific Recalls Saline Flush Syringes Due to Packaging Holes
FDA (Devices) · 2020-05-20
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