Medical device recalls

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Busse Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International (PDI), that are subject to a drug recall due to uncertainty of the adequacy of the validation of the test methods used to manufacture the drug products

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

Certain Peritoneal Dialysis product codes do not have FDA regulatory clearance and were distributed within the United States in error.

There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

There is a potential of reduced oxygenation or pneumothorax/barotrauma to occur when the Volara system is used with in-line ventilator in home care environment.

Product was shipped from a Medline warehouse to a customer at room temperature instead of refrigerated (ice). If affected product is used, the results from this impacted Calcium reagent will not be provided due to probable Quality Control failure. A delay in diagnosis may be experienced with repeat testing resulting in patient (customer) inconvenience, pain, and cost of the repeat blood draw and testing. All HII1220001954 product shipped/stored at a Medline branch between July 2021 and August 2021 in the identified lots were incorrectly stored and shipped. Six (6) boxes have been shipped to end users at room temperature instead of refrigerated (ice). Five (5) boxes are on hold at a Medline warehouse.

Inner pouch seal may be inadequate resulting in lack of sterility.

There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

There is a potential hazard of uninterrupted motion of the Motorized Wheel System due to the possible failure of a component in the electrical system of the Product.

Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.

Right nails were anodized, marked, and labelled as left nails and vice versa

There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.

Firm detected an increase in complaints related to fractured jaw tips of the Cardioblate Gemini-s.

The battery wiring harness on affected wheelchairs may become disconnected during shipment from the factory or during wheelchair use traversing large obstacles or after a jolt or impact to the wheelchair. The disconnection of the battery harness results in loss of power to the wheelchair.

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

The Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system.

Reports received of torn corrugated breathing tubes.

Reports received of torn corrugated breathing tubes.

Labeling error.

Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.

The Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system.