here are a few FDA recalls you might want to know….
1. Class 1 Recall for Carefusion Alaris Infusion Pump Model 8015 – read notice here
The issue: FDA notified healthcare professionals of a Class I Recall of the Alaris PC unit, model 8015. A component on the PC unit power supply board is causing an error code (120.4630): “System Error” or “Missing Battery Error” to occur. The error code is accompanied by both an audible alarm and a visual error message on the PC unit screen. If the error code occurs at start-up, the Alaris infusion pump cannot be programmed and this may cause a delay in patient therapy. If the error code occurs during infusion, the health care provider cannot make programming changes to current infusions, and this may result in serious injury and/or death to the patient.
Recommendation: On June 27, 2012, CareFusion sent an Urgent Medical Device Recall Notice to customers who purchased the Alaris PC unit, model 8015. CareFusion will contact customers by phone within 60 days of receiving the letter to schedule a visit to replace the affected power supply board on the PC unit.
- If the error messages are observed, remove the PC unit from use and contact the CareFusion Recall Support Center at 1-888-562-6018.
- For clinical areas administering high-risk infusions, consider having additional devices as back-up until affected devices are remediated.
2. Class 1 Recall for B. Braun Infusomat Space Infusion System – read notice here
The issue: FDA Notified healthcare professionals of a Class I Recall of the B. Braun Infusomat Space Infusion System, due to the potential for breakage of the anti free flow clip catch located inside the infusion pump door. Breakage may occur when the IV set anti free flow clip catch is inserted improperly into the pump and the pump door is forced closed. Misloading of the anti free flow clip catch may create the potential for free flow of medication. Free flow, especially of narrow therapeutic range drugs, can cause life-threatening effects and injuries.
Recommendation: B. Braun is contacting customers to make arrangements to have the metal clip catch added to all pumps, as well as modifying door jambs on certain models:
- All Infusomats on the market, which includes pumps with software versions G03, G02, or older, are being upgraded with a metal clip catch. This new material strengthens the clip catch and eliminates the potential for breakage of the current clip catch which is made of plastic.
- The door jamb on pumps with G03 software will be removed from the pump. The original intent of the door jamb was to minimize potential for breakage. However, it does not eliminate breakage when high forces are applied.
- Inclusion of pumps with software versions G02 or earlier. These customers were reminded about the importance of following the instructions for use to avoid potential IV set misloading. Customers were provided with information about the potential risks that may occur when instructions for use are not followed and the IV set is misloaded.
3. Hospira Injectable Drug Product Recall – Visible Particulates from Glass Vials Including certain lots of the following products: read article here
The ISSUE: Hospira and FDA notified healthcare professional of a nationwide recall of certain injectable drug products, due to visible particles embedded in the glass located at the neck of the vial. There may be potential for product to come into contact with the embedded particles and the particles may become dislodged into the solution. In the event in which particulate matter could be injected into a patient, there may be the potential for patient injury where medical intervention may be required. Signs and symptoms might include bleeding, bruising, inflammation, itching, rash, chest pain and respiratory symptoms.
RECOMMENDATION: Anyone with an existing inventory in the United States should stop use and distribution, quarantine the product immediately, and call Stericycle at 1-888-628-0734 between the hours of 8am to 5pm EDT, Monday through Friday, to arrange for the return of the product.