Recall Z-1983-2020— Access Scientific LLC
Class II · Terminated
Class II FDA medical device recall by Access Scientific LLC, initiated 2020-04-23, terminated 2021-04-27. FDA's recall record names no specific 510(k) clearance for this event. Product: BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - 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: Saline Flush Syringe compromised sterility due to holes in the packaging..
- Recalling firm
- Access Scientific LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-04-23
- Terminated
- 2021-04-27
- Firm location
- San Diego, CA, United States
Product description
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND XL 5Fr 8cm Max Barrier Kit. REF/UDI / 94116/10859821006237 - 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.