Medical device manufacturer, Cook Medical, has issued a medical device safety alert concerning its StoneBreaker Pneumatic Lithotripter and associated accessories. The products are listed below:

• Product Brand Name: A) StoneBreaker Pneumatic Lithotripter: B) StoneBreaker Exhaust Cap; C) StoneBreaker Exhaust Line; D) StoneBreaker Probe Cap; E) StoneBreaker Sterilization Cap; F) StoneBreaker CO2 Cartridge; G) StoneBreaker Single Use Probe.
• Catalog Identifier: A) SBL-KIT1; B) SBA-EC; C) SBA-EL; D) SBA-PC; E) SBA-SC; F) SBA-10; G) SBP-010500, SBP-010605, SBP-016500, SBP-016605, SBP-020425.
• Lot Number: All

The manufacturer is initiating a voluntary recall of the affected products, which are intended for reprocessing at the user's facility. The manufacturer has identified that the interior of the products may not be sterilized to the appropriate sterility assurance level when following the reprocessing instructions provided in the Instruction for Use (IFU).

According to the manufacturer, the potentially adverse events may occur include urinary tract infection, pyelonephritis, and urosepsis. The users are advised to examine inventory immediately to determine if they have affected products and quarantine affected products. Products recall is on-going.

According to the local supplier, the affected products are distributed in Hong Kong.

If you are in possession of any affected units, please contact your supplier for necessary actions.

Posted on 15 March 2018