Other Medical Devices

Due to 16 complaints related to drivers not engaging in implants. According to the firm's investigations, the incorrect offset gauge was potentially used during production of the implants. As a result, this could potentially lead to aborted or a delay in surgical procedure.

Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

Mislabeling; dual-bladder tourniquet cuffs are labeled as single-bladder inflatable cuffs.

Outer packaging (outer pouch) is not sealed compromising sterility and result in potential risk of patient infection, which could lead to revision surgery

Product stored incorrectly in temperature controlled setting instead of refrigeration.

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Missing bushing on Liko M220 and M230 causing wear and potential for patient falling

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

There is potential for separation between the threaded hub and threaded cap at the proximal end of the device.

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Incorrect marketing label (25 mm) was applied to product size 20 mm.

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin

Firm discovered that the wireless foot switch can suddenly stop responding due to a firmware issue. If the wireless foot switch fails, there could be a delay or interruption of procedure if the hand switch is not used or if the wired foot switch is not connected to the system.

Missing bushing on Liko M220 and M230 causing wear and potential for patient falling

The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.

The External Retention Bolster contained in the kit may be a larger diameter than the tube.

Guidewire included with two lots of Arterial Line Kits would not fit through the needle of the same kit. This could potentially lead to a slight delay in the procedure and minor blood loss.

Cleaning products, containing, but not limited to, hydrogen peroxide, bleach, alcohol, or antiseptic agents and solvent, such as those containing acetone, toluene, xylene, or cyclohexanone may cause damage, such as leaking or cracking, to the MiniCap Extended Life PD transfer sets.