FDA Device

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - 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.

Hazard

Saline Flush Syringe compromised sterility due to holes in the packaging.

What You Should Do

Remedy

Customer Service Department will send the Advisory Notice and Recall Response Form to all affected levels of the distribution chain. On 04/23/2020, the firm sent an Urgent: Medical Device Recall letter to heir distributors and hospitals requesting them to discard all BD PosiFlush" SF Saline Flush Syringe 10 ml (part number 306553) from the convenience kits.

Products

BD PosiFlush SF Saline Flush Syringe 10 mL used in POWERWAND" ED Quick Kit 3FR 6cm. REF/UDI 72627/ 00859821006674 - Product Usage: is used to gain access to the vascular system to sample blood and adm
Brand
Access Scientific LLC
UPC
LOT: 257828, 258294, 259262, 260814, 260173, 261861, 264561, 266804, 266805, 267191, 269121

Units Affected

2697 units