FDA Device recall Z-1973-2020
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is…
- FDA Device
- Class II
- terminated
- Published 2020-05-20
On 2020-05-20 the FDA classified a Class II recall of BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - Product Usage: is… by Access Scientific, citing saline Flush Syringe compromised sterility due to holes in the packaging.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1973-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-04-23 |
| Published | 2020-05-20 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Access Scientific |
| Distribution | US |
Product
BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND"XL Alternate Site Kit, 4Fr . REF/UDI 80701/10859821006213 - 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.
Identifiers
| code_info | LOTS: 259489, 259956, 261313, 262479, 263893, 265955, 266809, 267719, 268776 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1973-2020%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.