95,114 total recalls in our database
STERIS has identified that the control board software in select AMSCO 400 and AMSCO C units will interrupt and cancel a processing cycle should the selected sterilizer shutdown time coincide with a processing cycle. This may result in a procedure delay.
Siemens Healthcare Diagnostics has received complaints regarding panel degradation with a portion of the MicroScan Neg Breakpoint Combo 34 (NBP34) panel lot 2014-05-28.
Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
During a field audit it was discovered by an employee that a 16mm Trestle Luxe Screw has been both laser marked and labeled as a 14mm Trestle Luxe Screw (4.0mm Variable Angle, Self-Drilling Hexalobe Screw, 14mm). As a result the firm recalling the affected lots codes for this mislabeling.
Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
Bard Access Systems is conducting a field action due to the potential that an incorrect Maximum Flow rate label associated to the power injection IFU for the PowerLoc MAX Safety Infusion Set (SWIS) was attached to the outside of the unit pouch.
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Product distributed without 510(k) approval
The Acetate value for GranuFlo on the Select Concentrate screen should be 8mEq/l but it is displayed as 4mEq/l. The correct value is shown on the dialysate screen.
Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
Siemens investigation confirmed that a portion one lot of panel Pos Combo 33 lot was packaged without desiccants. The substrates on a panel packaged without a desiccant may deteriorate over time due to exposure to additional moisture in the panel pouch.
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
Integra LifeSciences Corp. d.b.a. Integra Pain Management
A single lot of 18 Gauge, 3.5 inch Tuohy Needles were incorrectly packaged and labeled as 18 Gauge, 5 inch needles.
An issue was identified with the mAs accuracy check performed on the system that could result in inaccuracies in the 10% to 20% range for exposure times longer than 15 msec.
The Anspach Effort
The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user.
Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
The pulse generators have a lower battery longevity than specified in their design requirement as a result of the devices being inadvertently left in a programmed ON state during manufacture.
Zimmer Gmbh
Complaints of difficulties to attach the Anatomical Shoulder Rasps (high resistance) or, once attached, due to difficulties to remove the handle (seizing up of the two components). This has the potential for delay in surgery.
Technical Support Bulletin issued in February 2013 did not mention performance limitation for Proteus mirabilis and Imp when using the CLSIM100-S20 revised interpretive criteria.
Should the Caviwave Pro Ultrasonic Cleaning System experience a temporary interruption in electrical power during a processing cycle, the circulation pump may stop functioning. In addition, it is possible that the ultrasonic generator may stop working. The machine does not provide an alert notifying the user of this device malfunction.