EQUISTREAM¿ XK Long-Term Hemodialysis Catheter. REF/UDI:5913190/(01)00801741013836; 16F
Bard Peripheral Vascular
🏥 Medical Devices Class I - Dangerous
Incorrect Peel-Apart Introducer Sheath in Kit.
All Recalls
95,114 total recalls in our database
🏥 Medical Devices Class I - Dangerous
In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
Custom Packs to be used in surgical procedures.
American Contract Systems
🏥 Medical Devices Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
🏥 Medical Devices Class I - Dangerous
Potential for discrepant patient results due to a potential for the primary sample tube to be diluted. In certain firmware versions, in case a Clot Detection error (error code E0E0 or 13E0) is generated during the sample aspiration the current error recovery procedure dispenses 2/3 of sample volume back into the Primary Tube. Evidence from the field showed that in case of Clot Detection error, this management may lead to the dilution of the Primary Tube with the distilled water of the hydraulic circuit of the Aliquoter Module.
🏥 Medical Devices Class I - Dangerous
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
🏥 Medical Devices Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
🏥 Medical Devices Class I - Dangerous
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
🏥 Medical Devices Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
🏥 Medical Devices Class I - Dangerous
Potential disconnection of tubing set.
🏥 Medical Devices Class I - Dangerous
Potential for disengagement of the Varian Style Type-S Extension during patient repositioning. The risk associated with the disengagement of the extension could be a patient fall if the patient is not supported by clinical staff.
🏥 Medical Devices Class I - Dangerous
The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
Sterile Custom Packs to be used in surgical procedures.
American Contract Systems
🏥 Medical Devices Class I - Dangerous
The surgical gowns were manufactured in a facility that is not registered by the FDA.
OLYMPUS ShockPulse-SE Lithotripsy System, Model SPL-T Transducer
Olympus Corporation of the Americas
🏥 Medical Devices Class I - Dangerous
A component of the Olympus ShockPulse Transducer was manufactured with non-conforming material that could allow water ingress during autoclaving sterilization.
🏥 Medical Devices Class I - Dangerous
The recalling firm characterized the potential interference effects of biotin (up to 1,200 ng/mL) on all biotin-mediated Access assays. The following six assays: Free T3-REF A13422, Total T3-REF 33830, Free T4-REF 33880, GI Mon-387687, Tg-REF 33860, and TgAbII-REF A32898 displayed significant interference (defined as a result bias greater than +/-10%) at 1,200 ng/mL of biotin.
🏥 Medical Devices Class I - Dangerous
The Bed Exit System may fail to send a remote alert through the nurse call system if a remote alert was previously sent and cancelled at the in-room nurse call wall unit.
🏥 Medical Devices Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
The labeling of the Philips Chest Pneumograph does not include a statement indicating that the product contains natural rubber latex.
🏥 Medical Devices Class I - Dangerous
There are reports of inadequate locking of the extended tab screws. Complaints were reported where the closure top backed out of the screw post-operatively.
🏥 Medical Devices Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.
🏥 Medical Devices Class I - Dangerous
Incorrect shelf-life for bone void filler kits; the product may not maintain its setting characteristics for the labeled shelf-life duration.