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Angiographic catheter tips may separate during use.
Aspiration errors in the conjugate component due to microbial contamination of the conjugate.
The 9.6 Fr. x 75 cm silicone rubber catheter was a higher durometer (less flexible) than previously provided.
CryoLife received information that an allograft associated with the donor had been linked to a complaint of an alleged positive pre-implant culture. Specifically Clostridium baratii was detected on the pre-implant culture performed at the implanting hospital site.
Some slides contain sporadic fields of positive and/or negative control inoculum in the test specimen area
Counterfeit product is an unapproved medical device with associated potential health hazard.
Assay is imprecise.
Counterfeit mesh product labeled as Ethicon Prolene Polypropylene Mesh, product code PMII.
Software anomaly allows results to be archived prior to validation or to be uploaded to the lab information system.
Packaging defects could result in improper mixing ratios and unusable impressions.
Surgical devices intended for single use were not labeled for single use.
False negative urine results are being observed at an increasing rate.
The manufacturer's instructions for using radiation treatment software may cause healthcare practitioner to mistreat the patient.
Mislabeled with wrong drop size drip chamber specification.
This wholesaler may have distributed some Prolene Mesh Counterfeit product with the Ethicon trademark.
Use of the dialyzers may cause iritis (red-eye) patient reactions.
Potential for power supply to fail resulting in failure of the audio (alarm tones) to fail.