Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack recall: Labeling Error
Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
Why was Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack recalled?
Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots
- Product
- Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)
- Recalling firm
- ZOLL Circulation, Inc.
- Quantity
- 334 bundles
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, SC, TN, TX, VA, WA, WI, WV and the countries Australia, CANADA, CHINA, GERMANY, HUNGARY, PORTUGAL, SINGAPORE, TAIWAN, THAILAND.
- Recall date
- October 13, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)