Other Medical Devices

Device is breaking while in use, potential for patients to require a revision surgery.

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different anatomies (Hip vs Knee).

Potential PCBA leaching from tubing of hemodialysis machines.

Potential PCBA leaching from tubing of hemodialysis machines.

Potential PCBA leaching from tubing of hemodialysis machines.

Potential PCBA leaching from tubing of hemodialysis machines.

Technopath Manufacturing Ltd. has identified an issue with the glass vial commodity used to fill the Multichem S Plus Level 1, Multichem S Plus Level 2, Multichem S Plus Level 3, Multichem IA Plus and Multichem P Controls. Some customers have experienced broken vials when receiving or thawing Technopath Multichem IA Plus and Multichem S Plus Controls. Breakages have been observed upon delivery, while thawing or while opening the vial. The breakages can result in the bottom of the vial breaking off, breakage in the neck thread area or cracking on the sides of the vial. This may expose the user to biohazardous material if cut and may cause a delay in patient results.

Certain vials of the BD BACTEC" Plus Aerobic/F Culture Vials have a labeling issue where duplicate barcode sequence numbers have been identified on more than one vial.

When global edit is used to update multiple formulary properties simultaneously, the following properties: 1) Require Lot Number on Recall, 2) Access Destruction Bin (Witness), 3) Add to Destruction Bin (Count/Empty), 4) CII Safe Stock Out Notice are, without user warning, overwritten to the value NO , which could result in diversion of controlled substances from the automated dispensing cabinet.

Potential PCBA leaching from tubing of hemodialysis machines.

Medical convenience kit contains Zimmer Dermatome Blades which were recalled by Zimmer due to 38 complaints received related to skin grafts being thin and non-uniform when using the affected blades.

The kits incorrectly contain CirClamp subassembly 345CRSAK which results in the kits containing an incorrect bell and base size.

The original version of the A71100 Restore Clinician Programmer Application has been identified to have a compatibility issue with some legacy clinician programmer software resulting in the programmer having an inability to establish communication with the implanted neurostimulators.

Inadequate internal fixation of the power inlet port to the cuff pressure manager device causes the external power inlet to became dislodged within the device housing after several uses, which prevents the device from being charged, and could lead to treatment delay.

In some cases, when lubricating grease is present within the headband of the over-ear headphones, it may cause visible, dot- or lineshaped, fat-isointense artifacts during head examinations only. These potential artifacts depend on the position of the headband, the amount of lubricating grease, as well as the sequence parameters used

After dispensing a timed dose medication for a patient, the automated dispensing cabinet software may continue to show the already dispensed medication dose is still available for dispense, which could lead to duplicate medication administration.

Expired Product distributed

In some cases the communication isolator installed in the Model 52X can cause a disturbance in the glass-filter safety circuit.

Product is labeled with incorrect offset.