Zoll Circulation Intravascular Heat Exchange Catheters Updated Instructions For Use (ICN 1410)
Important Customer Notice Field Safety Notice
NHSSC Ref: 51
- Following a Review of adverse events reported to the FDA between January 1 2019 and August 8 2021, Zoll Circulation is voluntarily conducting a field safety corrective action (FSCA) on the product labelling for all Intravascular Heat Exchange Catheters.
- The adverse events reported identified over 200 medical device reports (MDRs) that reported catheter balloon leaks associated with all ZOLL Intravascular Heat Exchange Catheters.
- See the urgent Field Safety Notice in our Downloads ▼ section for further details of these reports and potential consequences.
- Two of the products affected are available from NHS Supply Chain as:
|NPC||Product Description||Supplier Code/ MPC||Supply Route|
|VCB340||Intravenous Cooling Icy Catheter Kit||IC-3893AE||Blue Diamond|
|VCB341||Intravenous Cooline Catheter Kit||CL-2295AE||Blue Diamond|
The revised Instructions For Use now includes:
- Detailed step-by-step instructions on how to investigate/confirm potential leaks from either the catheter or the SUK.
- Multiple warning/caution/adverse reaction statements instructing users to avoid replacing depleted saline bags prior to identifying the location of the leak and taking the appropriate mitigation steps.
- The detailed leak investigation instructions, warnings, cautions, and adverse reactions associated with leaks from either the catheter or the SUK, on page 3.
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Complete and return the Customer acknowledgment Form, found on page 4, to IVTM_Recall@zoll.com as soon as possible.
- If you have any further questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanatavi (VP of Quality and Regulatory Affairs) via IVTM_Recall@zoll.com.