Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Class I - Dangerous

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    Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 1831000099, 20884521056555; 8888119364, 1832300114, 20884521056555; 8888119364, 2019500276, 20884521056555; 8888119364, 2106900226, 20884521056555; 8888123404, 1912600108, 20884521056586; 8888123404, 1934400172, 20884521056586; 8888123404, 2012100136, 20884521056586; 8888123404, 2017500130, 20884521056586; 8888123404, 2034400075, 20884521056586; 8888123404, 2104600236, 20884521056586; 8888123404, 2125800094, 20884521056586; 8888123404, 2127200415, 20884521056586; 8888123410, 2019500253, 20884521012988; 8888123410, 2104100079, 20884521012988; 8888128450, 2127200431, 20884521013008; 8888128454, 2017800061, 10884521056619; 8888128454, 1822600121, 20884521056616; 8888128454, 2017800061, 20884521056616; 8888128460, 2019500266, 20884521013053; 8888145014, 1715100153, 10884521013148; 8888145014, 1715800117, 10884521013148; 8888145014, 1715900177, 10884521013148; 8888145014, 1716100154, 10884521013148; 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  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Covidien Llc
Reason for Recall:
There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during use.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
ongoing

Product Information

Full Description:

Palindrome Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.

Product Codes/Lot Numbers:

Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 1831000099, 20884521056555; 8888119364, 1832300114, 20884521056555; 8888119364, 2019500276, 20884521056555; 8888119364, 2106900226, 20884521056555; 8888123404, 1912600108, 20884521056586; 8888123404, 1934400172, 20884521056586; 8888123404, 2012100136, 20884521056586; 8888123404, 2017500130, 20884521056586; 8888123404, 2034400075, 20884521056586; 8888123404, 2104600236, 20884521056586; 8888123404, 2125800094, 20884521056586; 8888123404, 2127200415, 20884521056586; 8888123410, 2019500253, 20884521012988; 8888123410, 2104100079, 20884521012988; 8888128450, 2127200431, 20884521013008; 8888128454, 2017800061, 10884521056619; 8888128454, 1822600121, 20884521056616; 8888128454, 2017800061, 20884521056616; 8888128460, 2019500266, 20884521013053; 8888145014, 1715100153, 10884521013148; 8888145014, 1715800117, 10884521013148; 8888145014, 1715900177, 10884521013148; 8888145014, 1716100154, 10884521013148; 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Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1316-2022

Related Recalls

Bedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response, respiratory failure, arrhythmia. Highlighting operator's manual: 1)For patient Safety don't silence/decrease alarm volume, 2)Sensor off alarm (no perfusion detected) is low priority alarm, 3)Set monitors to Homecare Mode outside of hospital/professional setting

Jun 23, 2025 Diagnostic Equipment Nationwide View Details →