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.
🏨
Other Medical Devices
🏥 Medical Devices • 15,203 recalls
ICU Medical ChemoLock Port REF: CL2100
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
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)
Class I - Dangerous
Product lacks 510(k) clearance.
Class I - Dangerous
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
Class I - Dangerous
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)
Class I - Dangerous
Product lacks 510(k) clearance.
Trial Tampon Box; Model Number: FG-TMP-REF04050504;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Class I - Dangerous
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)
Class I - Dangerous
Product lacks 510(k) clearance.
Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Various models of BD Pyxis Pro 7-Drawer Auxiliary, Reference numbers: 1149-00 and 1152-00
CareFusion 303
Class I - Dangerous
Potential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
MST ArcDUO 9mm, REF: ARC-0002, single-use, sterile ophthalmic knife, used with Suction Set, Part: 48-1000-01
MicroSurgical Technology
Class I - Dangerous
An ophthalmic knife has a suction set (not direct patient-contacting), which contains springs contaminated with an unidentified residue that may potentially cause eye irritation
Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
ICU Medical 8" (20 cm) Ext Set w/MicroClave Clear, ChemoLock Port, Y-Connector, Rotating Luer, REF: CL-3950
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.