Incorrect labeling was used on each pouch of the affected lots of APTIMA Urine Specimen Collection Kits. The outer box of the kits are identified correctly as "APTIMA Urine Collection Kits"; however, the inner pouches are incorrectly labeled as "APTIMA Unisex Swab Collection Kit for Endocervical and Male Urethral Swab Specimens."
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Other Medical Devices
🏥 Medical Devices • 15,809 recalls
Synthes External Fixation Systems (Small, Medium, Large and DO), bone fixation appliance components.
Synthes
Class I - Dangerous
Labeling changes have been made related to MR (Magnetic Resonance imaging) conditions as a result of changes in required protocols to designate a product MR Safe, MR Conditional, or MR Unsafe.
Class I - Dangerous
XVI can incorrectly calculate the target position of the treatment table.
Class I - Dangerous
A bug in the software prevents the iGUIDE software from logging off.
RayStation software version 4.0.3.4 RayStation is a software system designed for treatment planning and analysis of radiation therapy.
RAYSEARCH LABORATORIES AB
Class I - Dangerous
This notice concerns a problem with the computation of ROI voxel volumes for cases where the CT has variable slice spacing. The dose grid volumetric representation of an ROI can be wrong. This affects all dose-volume properties for such ROIs, including DVH, dose statistics, clinical goals and constraints or objective functions. Furthermore, if material override ROIs are used, or if the external is not represented by contours, the bug can trigger an error in the 3D dose distribution.
Class I - Dangerous
Convatec Inc. is recalling Flexi-seal FMS Control Kit since it does not have a 510K. In addition, an internal assessment of product performance, including a review of customer feedback, has confirmed that Flexi-Seal Control is not meeting expectations or those of customers. Specifically, the Auto-Valve feature that is unique to the Flexi-Seal Control has not been consistently performing relative
Class I - Dangerous
Light Image O-Spots Dispenser mislabeled as Soft n' Stretchy Light Image S-Spots
Class I - Dangerous
Beckman Coulter is initiating a field action because some Ultrasonic Transducer Kits were potentially assembled with incorrect mounting screws.
Class I - Dangerous
Product was packaged with a straight catheter rather than the correct coude (curved) catheter.
Class I - Dangerous
One lot of ventilation tubes have mixed tubes with wire attached to the slanted flange and ventilation tubes with wire attached to the straight flange. This poses no health hazard to the user or patient.
Class I - Dangerous
It was discovered internally that the face of the Synthes Matrix Mandible Short Cut Plate Cutter has the potential for discoloration/corroded material in the affected lot.
Class I - Dangerous
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
Class I - Dangerous
The ceiling mount supplier encountered an event in which the drive screw in the motor unit, which lifts and lowers the lower lift arm, broke. As a result, the lift arm fell down approx. 60 cm (23.6 inches).
NaturaLyte¿ Liquid Bicarbonate Concentrate, 6.4 liter bottle to be used with a hemodialysis unit; Part Number: 08-4000-LB. The concentrate is formulated to be used with a three steam hemodialysis machine which is calibrated for acid and bicarbonate concentrates.
Fresenius Medical Care Holdings
Class I - Dangerous
Container cap may contain foreign material- 0.60% - 0.80% Manganese
Stryker 5.0mm Barrel Bur Sterile
Stryker Instruments Div. of Stryker
Class I - Dangerous
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Cenorin LLC is voluntarily recalling HLD Systems Model 610 Washer/High Level Disinfector due to a potential risk of the system not injecting the proper amount of cleaning fluid during the wash cycle and not achieving the desired level of debris reduction.
Composix" LP with Echo PS" 6x10 Reorder Number: 0144610 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Davol, Inc., Subs. C. R. Bard
Class I - Dangerous
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
Bard¿ Ventralight" ST Mesh with Echo PS" 8"x10" Reorder Number: 5955810 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Davol, Inc., Subs. C. R. Bard
Class I - Dangerous
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.
CARINAsim MAN-1236 Rev 2 and CARINAiso MAN-1237 Rev 2 laser software. LAP isocenter marking control software. Laser systems for patient alignment.
LAP of America Laser Applications
Class I - Dangerous
Potential for patient to be marked incorrectly. Customers currently using CARINAsim or CARINAiso systems can encounter two safety relevant errors in the operating instructions (CARINAsim MAN-1236 Rev 2 / CARINAiso MAN-1237 Rev 2)
Bard¿ Ventralight" ST Mesh with Echo PS" 12"x14" Reorder Number: 5955124 Indicated for use in the reconstruction of soft tissue deficiencies, such as the repair of hernias.
Davol, Inc., Subs. C. R. Bard
Class I - Dangerous
Pouch holding sterile inflation assembly and inflation adapter may be open or have a weak seal.