The Recall Desk
ModerateFDA (Devices)·Z-0042-2022·Announced 2021-10-13

ZOLL Premium Access Kit SOLEX 7 Catheter Kit Labeling Update on Potential Leaks

ZOLL has issued a labeling update for its Premium Access Kit SOLEX 7 intravascular heat exchange catheter regarding potential leaks from the catheter or tubing. Approximately 5,524 kits were distributed worldwide.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported hospitalizations, injuries, or deaths. The hazard is described as potential leaks and is being addressed through a labeling update, indicating a precautionary measure rather than a response to documented incidents. Per the severity rubric, Class II recalls without reported harm and with theoretical hazards typically score as Moderate.

Plain-English summary

ZOLL Circulation, Inc. has issued a labeling update for the ZOLL REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, an intravascular heat exchange catheter kit with central venous infusion capabilities. The catheter is designed for use via jugular or subclavian vein approach and is supplied sterile for prescription use only.

The labeling update addresses the potential for leaks to occur from the catheter itself or from the start-up kit (SUK) tubing. This recall applies to all lots of the product, affecting approximately 5,524 kits that were distributed worldwide, including across the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

Healthcare providers and facilities currently using this device should consult the updated labeling information from ZOLL Circulation, Inc. For questions or further information about this recall, contact the manufacturer or the FDA.

The recalled product

Product
ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
  • leak

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All Lots

Distribution

Distributed nationwide across the United States.

Related recalls

Same category