Surgical Instruments

Resource Optimization & Innovation (ROi) has received a recall notice from Stryker regarding tube sets potentially detaching from the cassette, which can lead to leaking gas or a hissing sound.

Lasers/Catheters did not calibrate during set-up prior to use.

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.

Potential for occluded injection needles.

Manufacturing error, the drill bit shaft is unable to properly capture the drill bit pin. Failure of the drill bit shaft to capture the drill bit pin could result in the drill bit coming loose which could result in a delay in surgery or adverse patient reaction resulting in a revision surgery.

Kit lots contain a small percentage of damaged Filter-Tips that are leaking when being used with the QIAsymphony SP/AS Instruments (REF 9001297 and 9001301)

There is a potential for a loss of package integrity that may compromise the sterility of the product.

There is a potential for a loss of package integrity that may compromise the sterility of the product.

There is a potential for a loss of package integrity that may compromise the sterility of the product.

The syringes have scale markings that were printed incorrectly. The scale is skewed to varying degrees, resulting in missing and/or partially printed scale numbers and scale lines.

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

Mislabeled - The product's labeling contains an incorrect size for the catheter included in the kit. The kit contains a 21 gauge catheter, however the labeling states a 12 gauge catheter is included.

Manufacturing defect was found for the cartridge component, which could compromise the sterility barrier of the product

There is a potential for a loss of package integrity that may compromise the sterility of the product.

The sterility may be compromised due to a potential breach in the packaging, even though it may appear intact.