Medical Devices Recalls

During Ziehm Imaging GmbH FDA inspection, the label for the Collimator and X-ray Control panel was missing the manufacturer date as part of the identification for certified component

Current lots of ADVIA Centaur/XP/XPT/CP Insulin (IRI) assay recover approximately 40% higher than the World Health Organization (WHO) 1st IRP 66/304 standardization based on slope values. Other performance characteristics are being met per the assay Instructions for Use. Overall risk to health is negligible and Siemens is not recommending a review of previously generated results.

Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.

Over time, low-frequency vibrations can cause the pins within the female connectors on the Motor Controller to Data Acquisition Board ribbon cable to become partially displaced causing momentary high resistance that prevents or restricts data travelling through the cable during the high resistance event.

LeadCare Plus and LeadCare Ultra Blood Lead Testing Systems may generate falsely low lead concentrations in some blood samples. The issue is observed when blood samples are collected in tubes with lavender and tan rubber stoppers of the Becton Dickinson EDTA Vacutainer tubes, a collection device used with the testing system.

Vortran received a customer complaint that the spin-nut-DSS connector was assembled in the reverse direction on the oxygen tubing; making the connector unable to be screwed on due to the wrong thread direction.

Complaints concerning kinked haptics that were occurring during lens delivery.

Beckman Coulter has identified the following drugs as potential sources of interference: Metamizole (Dipyrone), Sulfasalazine, and Sulfapyridine and may result in false low results.

False susceptible results

Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .

Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

Products from the identified lots may exhibit difficulty in removing the protective balloon sheath which can result in issues with inflating or deflating the balloon.

A Discrepancy was found on Hitachi AST (HA7 61) package insert. Limitations section indicates linearity is 500 U/L and the Performance section linearity is listed as 0-600 U/L, which is not consistent with the 510k submission package insert.

Product's non-conformity involves the integrity of the seal in the sterile packaging. It is possible that the seal on the sterile packaging has been compromised resulting in a loss of sterility of the medical device contained within.

Zimmer Biomet is conducting a lot-specific medical device field action for two lots of the NexGen Offset Stem Extension implants. Product complaints indicated that the size etched on the part and labeled on the product packaging were incorrect.

Sorin is notifying physicians that certain defibrillators' battery depletion may be undetectable.

Packaging error. 20GA Vitrectomy Cutters may be found in a 25GA package and 25GA Vitrectomy Cutters may be found in a 20GA package.

Part of the number on the tray lid differ from the part number on the base.