Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Other Medical Devices
🏥 Medical Devices • 15,809 recalls
It was determined there is the potential of silicone fragments detaching from the yellow sealing component.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
All RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when used with Magellan Diagnostics LeadCare Testing Systems. False positive lead results may cause delayed results and additional unnecessary testing.
ICU Medical ChemoLock Port REF: CL2100
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 3 Month All in One Bundle; Model Number: FG-BNDL-PC-MM-IBAIO;
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
ICU Medical ChemoLock Bag Spike REF: CL-10
ICU Medical
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 36 Coated Super Tampons; Model Number: FG-TMP-MM-IB00360000;
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF;
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
DAYE (ANNE'S DAY LTD)
Product lacks 510(k) clearance.
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
CareFusion 303
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Port weld of drug transfer device may separate or break during use and potentially result in a leak.