The Recall Desk
ModerateFDA (Devices)·Z-0043-2022·Announced 2021-10-13

ZOLL SOLEX 7 Intravascular Catheter Kit Labeling Update for Potential Leaks

ZOLL Circulation, Inc. is updating labeling for SOLEX 7 intravascular heat exchange catheter kits to communicate about potential leaks from the catheter or start-up kit tubing. The update affects 5,345 kits with worldwide distribution.

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: FDA Class II recall with no reported illnesses, injuries, or hospitalizations. The hazard involves potential leaks, but without confirmed incidents of harm, this constitutes a precautionary labeling update.

Plain-English summary

ZOLL Circulation, Inc. is issuing a labeling update for the SOLEX 7 Intravascular Heat Exchange Catheter Kit (REF 8700-0793-40, Model SL-2593AE), a medical device intended for intravascular temperature management with heparin-coated central venous infusion capabilities. The update addresses potential leaks from the catheter or start-up kit (SUK) tubing.

The labeling update applies to all lots of the device, with 5,345 kits distributed worldwide, including throughout the United States and internationally to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand.

The recalled product

Product
ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravascular Catheter
Hazard
  • device-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