The Recall Desk
Agency classClass IIOur severity: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.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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
Affected units
5,524

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.

The notice also names 37 states specifically:

Part of a larger recall action

This product is one of 28 recalled by ZOLL Circulation, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 28 products in this recall →

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