🏥 Medical Devices • 7,015 recalls
Biosense is recalling the 20-Pole Eco Cable because it was incorrectly calibrated. When a catheter is connected to an affected to an affected 20-Pole Eco Cable, the catheter will not be recognized by the impacted 54 cable serial numbers within the field.
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Pessary mislabeled outer package may not reflect the size of the product contained in the package
Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.
Pessary mislabeled outer package may not reflect the size of the product contained in the package
The 1.6 mm Guidewire is undersized up to 2 mm in length. When used with the depth gauge, the measurement reading will not correspond with the desired screw length. The selected screw size based on the depth gauge reading will be about 2 mm longer than intended.
Some units may have been assembled incorrectly which could result in the boot breaking free from the mounting base and allowing the patient's leg to fall.
The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
Received 2 complaints out of 458 distributed pumps in this lot, where flow restrictor bead became displaced, which were reported to permit fast flow of contents.
In certain situations a software problem with the TotalCare SpO2RT¿ 2 bed may occur that can lead to inadvertent loss of sufficient surface cushion pressure to adequately support the patient. This may increase the likelihood of skin irritation for patients at higher risk of developing pressure-related skin conditions. A correction to the software program is currently being developed and tested,
The Straight Ringloc Button Latch Inserter Handle may have been manufactured at the higher end of the tolerance causing interference with the Ringloc cup. The inserter handle may lock onto the cup during impaction. If alternative inserters are not available this could cause a surgical delay greater than 30 minutes.