Z-0056-2022Class II
Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with...
ZOLL Circulation, Inc. / initiated 2021-08-06 / Terminated / root cause: labeling and UDI
ZOLL Circulation, Inc. began a recall of Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens)... on . FDA classified it as Class II and gives the reason as "Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing". As of , the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-0056-2022
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- ZOLL Circulation, Inc.
- Product
- Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077
- Product code
- NCX System, Hypothermia, Intravenous, Cooling
- Reason for recall
- Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling design
- Action
- Between the dates of August 27, 2021 and September 3, 2021, ZOLL, issued an "Urgent Medical Device Recall (Correction)" Notification to all affected US consignees via UPS. In addition to informing consignees about the labeling correction, Zoll asked consignees to take the following actions: 1. If you have any questions, please contact Doug Lam (Director of Quality and Compliance) or Sam Nanavati (VP of Quality and Regulatory Affairs) at [email protected]. 2 Provide this notice (letter) to all those who need to be aware within your organization or to any organization where the affected devices have been transferred. 3 Maintain a copy of the recall notification and attachment with the IFU for reference. ZOLL will provide a method to obtain the updated IFU once it is released. 4 If you experience any adverse reactions or quality problems with the use of our products (catheters), you may report adverse reactions or quality problems to the FDA s MedWatch Adverse Event Reporting program either online (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=consumer.reporting1), by regular mail or by fax (1-800-332-0178). 5 Sign and return the pre-stamped post card (enclosed) acknowledging that you have read and understood the content and requirements on this recall notice (letter) within 5 working days from receipt of this notice. 6. If you do not believe that you are the right person to implement the above-mentioned actions, please forward this letter to the right person in your organization. Actions Underway by ZOLL: 1. ZOLL will submit a revised IFU to FDA with heavy focus on providing clear instructions to the users on how to investigate/mitigate a potential catheter leak whenever a depleted saline bag is noticed by the users. 2. ZOLL will provide all affected users a method to obtain the revised IFU once it is reviewed and cleared by the FDA. 3. ZOLL is retraining all Sales staff to the revised IFU. 4. If we could be of any further assi
- Quantity in commerce
- 3 units
- 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.
- Product codes and lots
- All Lots
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0039-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0040-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0041-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0042-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0043-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0044-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0045-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0046-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0047-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0048-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0049-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0050-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0051-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0052-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0053-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0054-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0055-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0056-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0057-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0058-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0059-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0060-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0061-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0062-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0063-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0064-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0065-2022 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-0066-2022 | Class II | Terminated | Voluntary: Firm initiated |
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