Instrumentation Laboratory: GEM Premier 3000 PAK Cartridges Recalled for Inaccurate Oxygen Readings

What You Should Do

1. Identify if you have any of the affected GEM Premier 3000 PAK cartridges by checking the Part Numbers and Lot Numbers on the packaging. Affected Part Numbers include 00024307504, 00024330004, 00024345004, 00024307507, 00024315007, 00024330007, 00024345007, 00024360007, 00024315009, 00024330009, 00024345009, and 00024360009.
2. Specific lot numbers for Part 00024307504 include 324230M and 323630G; for Part 00024330004, check for lots 325655C, 322355C, 323755H, 323855E, and 326255D; for Part 00024315009, check for 26 unique lots including 323442F, 323142D, and 326442F.
3. Compare your Unique Device Identifiers (UDI) against the recalled list, such as 08426950087922, 08426950082507, 08426950082538, 08426950087946, 08426950082484, 08426950082514, 08426950082545, 08426950082569, 08426950082491, 08426950082521, 08426950082552, and 08426950082576.
4. If you are a healthcare provider using these cartridges, contact your healthcare provider or Instrumentation Laboratory directly to discuss the impact on patient care and instructions for returning or replacing the cartridges.
5. Contact the manufacturer, Instrumentation Laboratory, at their Bedford, MA location or via their customer support channels for more specific instructions regarding this voluntary recall.
6. For additional information or to report adverse events, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Affected Products