By: Russell Maas | Published: October 7th, 2013
Hospira Inc. has announced that it is recalling a particular lot of numbing fluid used before surgery, after confirming the presence of particulate matter in the fluid that poses a risk of inflammation, phlebitis, and occluded capillaries for patients.
The Hospira lidocaine injection recall was announced by the FDA on October 4, after the manufacturer was able to confirm that visible particulate matter in the solutions is oxidized stainless steel, which poses an increased risk to patients receiving magnetic resonance imaging (MRI).
The recall includes Hospira Inc. 1% Lidocaine HCI Injection fluid packaged in 10 mg/mL and 20 mL Multiple-Dose Fliptop Vials with NDC number 0409-4276-01. The recalled vials have lot number 25-090-DK that may be followed by the number 01 or 02. The fluids were manufactured by Hospira Inc. and distributed from March 2013 through June 2013 to various hospitals and physicians.
Particulate matter in injection fluid can be extremely dangerous depending on the size and material of the foreign objects. Typically small particulate matter will cause phlebitis, mechanical disruption of tissue or local inflammation at the area of injection. Larger particulate matter may interfere with the injection and block the passage causing a delay in treatment. In more severe cases capillaries may become occluded and build up in the lungs.
Stainless steel particulate matter increases the risk of patients who will undergo magnetic field exposure during treatment because if the particles travel into the lungs and the magnetic resonance imaging dislodges them, it may cause hemothorax or pnemothorax, which requires significant medical intervention.
Hospira has been associated with multiple recalls over the past few years due to particulate matter contamination. Just last week Hospira issued recalls for generic Reglan and generic Zofran, after injectable versions of the drugs were found to contain strands of glass.
Earlier this year, Hospira Inc. recalled one lot of .09% sodium chloride injection following a consumer complaint indicating particulates within the fluid which after further investigation were identified in four tested samples. In September Hospira recalled a lot on Amino Acid injection fluid that was confirmed to be contaminated with human hair follicles.
Hospira recommends that those with existing inventory stop using it immediately, quarantine the product, and contact Stericycle at 1-866-364-8812 to arrange a return and replacement of the product. Clinical inquiries should be directed to either Hospira Global Complaint Manager at 1-800-441-4100 or Hospira Medical Communications at 1-800-615-0187.