Z-1980-2020 Class II Terminated
FDA device recall Z-1980-2020 was initiated by Access Scientific LLC on April 23, 2020 and is designated Class II. Reason for recall: Saline Flush Syringe compromised sterility due to holes in the packaging. The recall status is terminated (terminated April 27, 2021). Affected quantity: 4,187 units.
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2020
- Initiation Date
- April 23, 2020
- Termination Date
- April 27, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4,187 units
Product Description
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 3Fr 6cm Quick Kit. REF/UDI / 94123/10859821006473 - 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 media up to a rate of 8 ml/sec and at a maximum of 325 psi fluid pressure.
Reason for Recall
Saline Flush Syringe compromised sterility due to holes in the packaging.
Distribution Pattern
US Nationwide distribution 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, UT, WA.
Code Information
LOTS:257866, 259929, 260815, 260982, 264749, 267192, 267193, 269120