Following a year of unprecedented recalls, another unit of embattled drug giant, Johnson & Johnson, is issuing a medical device recall, this time, for <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">2.0 mL Animas Insulin Pump Cartridges.
Some 2.0 mL insulin cartridges shipped between November 30, 2010 and January 4, 2011, can leak insulin. This defect can result in under-dosing of insulin, which can cause high blood sugar and/or diabetic ketoacidosis both serious conditions that can cause severe adverse reactions, including death.
Symptoms of diabetic ketoacidosis may include nausea, vomiting, shortness of breath and excess thirst/urination. Contact your healthcare professional immediately if you are experiencing any of these symptoms.
The leak is at the plunger side of the cartridge, resulting in under-delivery of insulin during basal or bolus of insulin. Also, the medical device defect can also cause the pump to fail to alarm if an occlusion occurs in the infusion set.
Animas is advising patients to immediately check their cartridge supply and to stop using the recalled insulin pump cartridges immediately. Involved cartridge lot numbers are: B201575, B201576, B201581, B201582, and B201583. The lot number appears on the side panel of the cartridge box and on the packaging of each individual cartridge. The recalled lots were all shipped in the United States.
Animas will replace any recalled product that is still in the patientâ€™s possession, free of charge.
Should a patient be in possession of one of the lots with the defective insulin pump cartridge, the cartridge should be changed immediately according to the directions provided by Animas to healthcare providers, which also contains complete product recall information. The letter, in PDF format, can be accessed at: http://www.animas.com/sites/default/files/pdf/20mL_cartridge_us_website_update_letter_and_faqs.pdf. The instructions are also further detailed in the Owners Booklet or User Guide.
Patients are advised against adjusting basal or bolus rates to correct the under-delivery of insulin and are advised to stop using the cartridge immediately and replace it with a cartridge from a lot that has not been affected. Patients with no additional cartridges are advised to refer to the backup insulin administration plan pending a free replacement supply, or to contact their healthcare professional for additional guidance concerning insulin dosing.
Supplies of new 2.0 mL insulin cartridges replacing the existing, recalled supply have been sent and all replacement cartridges were sent free of charge and are clearly affixed with a green dot for ease of identification and to ensure they are not confused with the affected cartridges that must be returned. Replacements were shipped by the Animas Cartridge Fulfillment Center to the address on file for each patient and include return labeling. If the replacements were not received, contact Animas Cartridge Fulfillment Center, toll-free, at 1-877-280-2339.