Medical Devices Recalls

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Incorrect size was printed on the outer product packaging.

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.

Lost and incorrect images. When using the "F-Rec" fluoroscopy image acquisition recording option in the "manual mode" an infrequent software error may cause images from another study to be displayed on the monitor. The acquired images may be lost requiring additional image acquisitions to be performed.

Small holes (approximately 1 mm or less) found in device unit level packaging potentially compromising product sterility.

Some individual container filter units might contain thin areas that may potentially compromise the ability of the filter to maintain a sterile barrier.

Lifecodes PF4 Enhanced assay, lot number 3000389, is being recalled because of observed inconsistent replicate values when testing the kit Positive Control and patient samples. The variation in reactivity can lead to invalid assays. If an invalid assay is obtained, those results should not be reported and the test should be re-run. An invalid assay would not result in significant harm to a pati

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

In the course of the firm's product monitoring activities, a potential risk for patient or operators was determined during the operation of an Artis zeego system with software revision VC14, VC20 and VC21 in conjunction with a specific technical configuration which cannot be completely executed.

Abbott has identified that assay files for the ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory assays (LNs 4P53 and 4P54) on the ARCHITECT i1000SR System were mistakenly made available on abbottdiagnostics.com in October 2012. Additionally, some i1000SR customers received notification through AbbottLink in November 2012 that assay files for LNs 4P53 and 4P54 were available. The AR

Pessary mislabeled outer package may not reflect the size of the product contained in the package

Microbiologics Inc is initiating a voluntary recall on products KWIK-QC Acid Fast Stain Slide, SL42-10 and KWIK-QC Mycobacterium, SL43-10. These products are being recalled because the control organisms are not properly fixated on the slide, which may cause the user to unintentionally contaminate the patient area of the slide by flooding the control well with stain. This contamination could pote

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

An internal review of CareFusion's labeling for preoperative skin prep product codes was recently conducted. The labeling of the product codes identified above state that the contents of the package are sterile and does not clarify that this sterility claim is only applicable to the applicator. The antiseptic solution that is applied to the skin is a cutaneous disinfectant, and is not sterilized.

INTIO Inc. distributed a SVM User's Manual and it has an editing mistake that could be interpreted as promoting an unapproved use.