Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
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Other Medical Devices
🏥 Medical Devices • 15,203 recalls
ICU Medical 6" (15 cm) Ext Set w/MicroClave" Clear, ChemoLock" Port, Y-Connector, Rotating Luer REF: CL4118
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF;
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.
Class I - Dangerous
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
Greiner BIO-ONE VACUETTE 2 ml 9NC Coagulation sodium citrate 3.2%, REF: 454322
Greiner Bio-One North America
Class I - Dangerous
Blood collection tubes were manufactured with the label applied too high on the tube, which shifted the printed fill level mark upward, which could result in unnecessary sample rejection and repeat collections.
Initiation 18 Coated Regular and 18 Coated Super Tampons; Model Number: FG-TMP-MM-IB18180000;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Initiation 18 Coated Regular and 18 Nude Regular Tampons; Model Number: FG-TMP-MM-IB18001800;
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.
18 Coated Super Tampons; Model Number: FG-TMP-REF00180000;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
ICU Medical 7.5" (19 cm) Appx 1.5 ml, Ext Set w/ChemoLock" Port, Clamp, Graduated Adapter REF: CL3967
ICU Medical
Class I - Dangerous
Port weld of drug transfer device may separate or break during use and potentially result in a leak.
Regular Flow Bundle; Model Number: FG-BNDL-PC-REFRF;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
9 Coated Regular and 9 Nude Regular Tampons; Model Number: FG-TMP-REF09000900;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
Refill 36 Coated Regular Tampons; Model Number: FG-TMP-MM-REF36000000;
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.
Refill 3 Month Trial Tampon Box; Model Number: FG-TMP-MM-REF09090909;
DAYE (ANNE'S DAY LTD)
Class I - Dangerous
Product lacks 510(k) clearance.
ChemoLock Bag Spike, 01 units REF: CL-10-10
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
There is a potential safety issue associated with the magnet venting paths of the Siemens 3 Tesla MRI system within your IMRIS Operating Suite. Siemens notified IMRIS that an ice blockage may exist within the magnet venting system. In the event of a quench, helium gas may be unable to escape through the designed vent paths, leading to a pressure build-up within the helium containment system which could ultimately rupture the helium containment system, potentially resulting in a helium leak into the scanning room.
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.