All Recalls

Presence of Foreign Substance: possibility of the presence of metal in the product.

Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.

May result in elevated platelet backgrounds during routine startup/background checks.

Software issue

Software bug which allows parameters to be changed unintentionally during use.

When samples are prepared using the PrepPlus or PrepPlus 2 sample preparation systems and then run on a Flow cytometer, there is an imprecision in the absolute counts on only the first tube in a run.

A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.

Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.

Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.

Potential for electric shock in the case of a failure to install the grommets, supplied with the system.

Smiths Medical became aware on January 11, 2017, that syringe assemblies provided by Nipro Medical Corporation contained pin holes in the side wall of the hub. The defect was not detected during Smiths Medical incoming inspection. The syringe assemblies were used to manufacture seven (7) finished good lots of Hypodermic Needle Pro¿ needles, Smiths Medical part numbers EL 1915 and SB5021.

Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices and thus require, but do not currently have, premarket review and approval.

Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be above the balloon

One lot of product does not include a screw for attachment to the tibial base plate.

Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.

Incorrect labeling for specified voltage for the Alarm Connectors on the rear side of the unit.

Product was improperly labeled leading to improper storage.

Software error. In Sensis Vibe systems with software version VD10B, a software error can result in: problems generating a report and/ or - information from different examinations of the same patient being combined into one report. --- The error causes information from two examinations to be combined into one report. This does not result in a hazardous situation; however, if the erroneous report has been used for treatment or diagnosis, this can potentially result in an incorrect treatment or diagnosis.

Mis-pack. A size 6 Left 3DKnee Tibial Insert box and pouch contained a Size 8 right 3Dknee Tibial Insert.

Recall is being initiated to address on-site software installations not being performed consistently with IBA standard operating procedures.