Recall Z-0042-2022— ZOLL Circulation, Inc.
Class II · Terminated
Class II FDA medical device recall by ZOLL Circulation, Inc., initiated 2021-08-06, terminated 2024-10-18. It names one FDA 510(k) clearance: K153226. 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:. Reason: Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing.
- Recalling firm
- ZOLL Circulation, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2021-08-06
- Terminated
- 2024-10-18
- Firm location
- San Jose, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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:
Reason for recall
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
Data sourced from openFDA. This site is unofficial and independent of the FDA.