ISSUE:
Hospira, Inc. announced the voluntary recall of certain lots of several
products in its LifeCare line of flexible intravenous solutions due to
the potential for leakage. The issue was identified during
re-inspection of a manufactured product lot in which a single puncture
mark was identified going through the overwrap and primary container.
The puncture in the primary container may result in leakage that is
difficult to detect. Leakage may result in an open system, which has the
potential for contamination, compromised sterility, drug waste,
spillage, inadequate or inconsistent solution/medication dosing, and/or
delay in therapy, all of which may require medical intervention.
Hazardous topical exposure may occur if a hazardous drug is added to the
flexible container. To date there have been no reports of adverse
events associated with this issue for the impacted lots.
BACKGROUND:
The affected lots were originally distributed by Hospira to direct
accounts from September 2013 through October 2014. The root cause is
attributed to a defect in a conveyance system, and corrective actions
have since been implemented to prevent a reoccurrence. The manufacturing
issue that caused this incident has been addressed.
RECOMMENDATION: See the Firm Press Release
for a list of the recalled lots. Anyone with an existing inventory of
the recalled lots should stop use and distribution and quarantine the
product immediately. Hospira will be notifying its direct customers via a
recall letter and will arrange for impacted product to be returned to
Stericycle. For additional assistance, call Stericycle at
1-844-861-6221 between the hours of 8am to 5pm ET, Monday through Friday.
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