Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg
Thursday, March 13, 2014
Merit Medical Systems, Custom Procedural Trays/Kits Containing 1% Lidocaine HCl Injection, USP, 10mg/mL: Class I Recall — Particulates Found in Hospira supplied 1% Lidocaine HCl
PRODUCT: Custom Procedural Trays/Kits containing 1% Lidocaine HCl Injection, USP, 10 mg/mL Lot # 25-090-DK; See Lot Numbers for Custom Procedural Trays or Kits.
USE: Custom procedural trays or kits are a combination of legally marketed medical devices placed into one container for the convenience of the user and used within the limits of the products’ intended uses.
ISSUE: Hospira, Inc. is recalling one lot of 1% Lidocaine HCl Injection which is contained in the Custom Procedural Trays/Kits. These trays/kits were recalled due to one confirmed customer report of visible particulate, identified in the primary product container, in the form of dark red/black particles.
The particulate was identified as oxidized stainless steel. If oxidized stainless steel particulate is undetected, there is a potential to be injected and/or result in delay in therapy. These effects have the potential to result in serious life-threatening complications requiring medical intervention.
The presence of oxidized stainless steel particulate may potentially put a patient at risk from a strong magnetic field exposure such as with magnetic resonance imaging (MRI). If a metal particle in the lung becomes dislodged and pulled through tissue, possibly causing a collapsed lung (pneumothorax) or blood in the space between the chest wall (hemothorax), urgent and significant medical intervention may be required. The presence of oxidized stainless steel particulate could also result in blood clots in the lung and a stroke.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch Safety Alert, including links to the Firm Press Release at: http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm389080.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery
Source: U.S. Food and Drug Administration (FDA) (Accessed: 3/13/2014)