The Recall Desk
HighFDA (Devices)·Z-0066-2022·Announced 2021-10-13

Zoll SOLEX 7(Heparin) IVTM Kit Recall: Potential Catheter and Tubing Leaks

ZOLL Circulation is recalling 322 bundle kits of SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit due to potential leaks in the catheter or start-up kit tubing. The affected kits have been distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device with potential for harm (leaks in catheter and tubing connections). No reported illnesses or injuries are mentioned in the source material. Per the severity rubric, this qualifies as High (3) because it represents a risk-of-harm product where injury has not yet been reported.

Plain-English summary

ZOLL Circulation, Inc. is recalling the SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (REF 8700-000872-40). The recall involves 322 bundle kits distributed worldwide, including across all US states and to Australia, Canada, China, Germany, Hungary, Portugal, Singapore, Taiwan, and Thailand. All lots of the affected product are included in this recall.

The recall is a labeling update due to potential leaks from the catheter or the start-up kit tubing. This Class II medical device recall was issued by the U.S. Food and Drug Administration. Additional information about this recall is available from the FDA or from ZOLL Circulation, Inc., the recalling manufacturer.

The recalled product

Product
Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer
Manufacturer
ZOLL Circulation, Inc.
Category
Medical Device — Intravenous Infusion Kit
Hazard
  • catheter-leakage
  • tubing-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