Medical Devices Recalls

The firm is recalling sterile enteral feeding syringes due to determining that the sterility of the affected products may be compromised as a result of a potential breach in packaging.

Improper installation of Tube arm, and Wall stand may cause it to fall down, Improper installation of table may cause it to float.

The firm received complaints regarding multiple mattresses were showing failures resulting in pressure ulcers.

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

Some units of the EVOLUTION Tibial Base was affected by a casting tool issue which caused varying retaining wall thickness and keel offset in the finished product.

Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal Health Solutions acquisition of the Apollo product line.

An increase in complaints of loosening and radiolucent lines.

In combination with the Batch Programming option (only) for programming samples, the hand-held barcode scanner unexpectedly skips sample cup positions within a sample tray. This issue only occurs when using the Batch Programming option; all other sample programming options function as intended.

A false negative result affecting the diagnosis may occur. A defect in the syringe assembly stopcock component may, in some circumstances, cause leakage of excess buffer onto slide location 34 on the AS480, or slide locations 35 and 36 on the AS100, S3400, and S3800. Affected dates are from 12/2013-08/2014.

Capillary Caps for RAPIDLyte Multicap and Multicap-S Blood Collection Capillaries may not attach and result in breakage of the glass capillary

Neonatal bilirubin (nBili) parameter may have increased variability when the nBili concentration is greater than 12 mg/dl and the tHb concentration exceeds the upper reportable range of greater than 25 g/dl.

The system does not provide the appropriate audible signal, permanent activation, and manual override, although the system is in high-level control functionality

The firm is informing customers of a software error that might result in an inaccurate display of the Temp Basal time and duration in CareLink Clinical reports with data uploaded from the MiniMed 620G or 640G insulin pump.

Defect: A hole or crack was found which may cause air to leak.

There is the possibility that the Vacuum Source Tubing set for the Endo Wrist Stabilizer may have the outer pouch compromised during shipping, resulting in small pinholes which compromise the sterility of the pouches outer surface.

ADVIA Centaur Systems Progesterone Kit Lots Ending in 268 have a high bias on results greater than 30 ng/mL (95.4 nmol/L)

The recalled devices labeling and instructions for use contain unapproved medical claims.

Defect: A hole or crack was found which may cause air to leak.