Surgical Instruments

Loose silicone particulate was found to be present on the shaft of the silicone catheters.

Unexpected stress fractures on the shaft of the hand piece may result in fragmentation during clinical use.

The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.

The products have the potential to leak between the connection of the male luer and the yellow striped tubing. This leak may be observed while priming or during use. The most likely health consequence associated with a leak in an administration set would be inadequate pain control for the patient due to an under-infusion of medication.

Saline Flush Syringe compromised sterility due to holes in the packaging.

DeRoyal manufactured procedure packs using BDPosiFlush syringes which were subsequently recalled due holes in the packaging.

When analyzer sample carousel lid remains open or manual process is too long, Module timeout expiry errors could occur causing cross contamination of samples.

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Sterile catheter kit packaging compromised.

Due to a manufacturing variation in the arm that can result in a persistent recoverable fault error (error 23087) and loss of arm functionality prior or during surgery.

Arterial Line Kits include thicker curved reverse-cutting needle with a 0-silk suture, instead of the usual straight-cutting needle with a 3-0 silk suture. The thicker suture may be more difficult to tie. The curved needle requires the use of a needle driver, there is a risk of needle stick to the surgeon tries to do it with fingers instead.

The firm has become aware there is a potential problem with its DABRA catheters resulting in higher catheter calibration failure rate due to the product shelf life is currently less than the labeled shelf life.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Saline Flush Syringe compromised sterility due to holes in the packaging.

Iincorrectly packaged without the required lidocaine as labeled