Hospira has announced a voluntary recall of one lot of Lactated Ringer’s Irrigation 3000mL following a confirmed customer report of several dark, fibrous particulate floating within the solution of the primary container.
The particulate has been confirmed to be Aspergillus kanagawaensis, a non-toxic, non-invasive mold. The administration of a contaminated solution may cause bacteremia, sepsis, septic shock, endocarditis, and possibly death. Signs and symptoms may include redness, pain, swelling at the site, fever, shortness of breath, tachycardia, nausea, and vomiting. Exposure to the mold may cause an allergic or immune response including anaphylaxis. If the particulate were to block the irrigation, it may result in delayed therapy.
Lactated Ringer’s Irrigation is a sterile solution that contains electrolytes in water indicated for sterile irrigation, washing, and rinsing purposes. The affected product has Lot# 40-008-JT, NDC# 0409-7828-08, and an expiration date of 1APR2016. The product lot was distributed to wholesalers, distributors, surgery centers, and hospitals from June 2014–September 2014.
Hospira will be notifying its direct customers via a letter and is arranging for return of affected product.
For more information call (877) 907-7037 or visit FDA.gov.