Other Medical Devices

Incorrect expiration date on product label. The manufacturing date was listed as the expiration date. Correct expiration date is "22.07.2027"

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Select catheter lots were identified to be labeled with incorrect expiration date, where the catheters expire prior to the labeled expiration date of the kit.

This is a potential problem with the locking mechanism that is used to secure the PET gantry in either its scanning or service position.

Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.

Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Face masks were placed into the incorrect dispenser boxes. The face masks come with ear loops, but the dispenser is incorrectly labeled as face masks with ties instead of ear loops.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.