🔍 RecallPedia

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

Class I - Dangerous
🏥 Medical Devices Recalled: June 8, 2022 Covidien Surgical Instruments Nationwide

What Should You Do?

  1. Check if you have this product:
    Code Information organized as "Model No., Serial No., GTIN": 8888119365, 1925200097, 20884521012810; 8888119371, 2031800117, 20884521056562; 8888123405, 2028200168, 20884521012940; 8888123405, 2127200428, 20884521012940; 8888145043, 1932200082, 10884521013223; 8888145043, 2003700042, 10884521013223; 8888145043, 2014900147, 10884521013223; 8888145043, 2023300169, 10884521013223; 8888145043, 2031800113, 10884521013223; 8888145043, 2034400185, 10884521013223; 8888145043, 2104600104, 10884521013223; 8888145043, 2108100054, 10884521013223; 8888145043, 2127200539, 10884521013223; 8888145043, 1919700110, 20884521013220; 8888145043, 1929500076, 20884521013220; 8888145043, 1932200082, 20884521013220; 8888145043, 2000700103, 20884521013220; 8888145043, 2003700042, 20884521013220; 8888145043, 2014900147, 20884521013220; 8888145043, 2019200001, 20884521013220; 8888145043, 2023300169, 20884521013220; 8888145043, 2028200174, 20884521013220; 8888145043, 2031800112, 20884521013220; 8888145043, 2031800113, 20884521013220; 8888145043, 2034400185, 20884521013220; 8888145043, 2034400187, 20884521013220; 8888145043, 2104600100, 20884521013220; 8888145043, 2104600104, 20884521013220; 8888145043, 2108100054, 20884521013220; 8888145043, 2108100055, 20884521013220; 8888145043, 2108100056, 20884521013220; 8888145043, 2109700070, 20884521013220; 8888145043, 2116500163, 20884521013220; 8888145043, 2124500119, 20884521013220; 8888145043, 2127200539, 20884521013220; 8888145043, 2127200540, 20884521013220; 8888145043, 2127200541, 20884521013220; 8888145044, 1922500109, 10884521013247; 8888145044, 1922500112, 10884521013247; 8888145044, 1925200063, 10884521013247; 8888145044, 1933700119, 10884521013247; 8888145044, 2000700104, 10884521013247; 8888145044, 2104600101, 10884521013247; 8888145044, 2106900137, 10884521013247; 8888145044, 2110900104, 10884521013247; 8888145044, 2113400084, 10884521013247; 8888145044, 2116200117, 10884521013247; 8888145044, 2200300118, 10884521013247; 8888145044, 1922500109, 20884521013244; 8888145044, 1922500110, 20884521013244; 8888145044, 1922500112, 20884521013244; 8888145044, 1925200063, 20884521013244; 8888145044, 1929500075, 20884521013244; 8888145044, 1929500092, 20884521013244; 8888145044, 1933700119, 20884521013244; 8888145044, 2000700104, 20884521013244; 8888145044, 2104600101, 20884521013244; 8888145044, 2104600102, 20884521013244; 8888145044, 2104900109, 20884521013244; 8888145044, 2106900137, 20884521013244; 8888145044, 2110900104, 20884521013244; 8888145044, 2113300436, 20884521013244; 8888145044, 2113400084, 20884521013244; 8888145044, 2116200115, 20884521013244; 8888145044, 2116200116, 20884521013244; 8888145044, 2116200117, 20884521013244; 8888145044, 2124500106, 20884521013244; 8888145044, 2124500121, 20884521013244; 8888145044, 2200300118, 20884521013244; 8888145045, 1929500093, 10884521017900; 8888145045, 1933700120, 10884521017900; 8888145045, 2004400084, 10884521017900; 8888145045, 2110900143, 10884521017900; 8888145045, 2113400059, 10884521017900; 8888145045, 1822000073, 20884521017907; 8888145045, 1929500093, 20884521017907; 8888145045, 1933700120, 20884521017907; 8888145045, 2004400084, 20884521017907; 8888145045, 2110900143, 20884521017907; 8888145045, 2113400059, 20884521017907; 8888145045, 2124500087, 20884521017907; 8888145046, 1927500059, 20884521013268; 8888145046, 1927500060, 20884521013268; 8888145069, 2017600095, 20884521056708; 8888145070, 2026000154, 20884521056715; 8888145043C, 1924600101, 10884521056305; 8888145043C, 1926100282, 10884521056305; 8888145043C, 2002900150, 10884521056305; 8888145043C, 2014900156, 10884521056305; 8888145043C, 2017500125, 10884521056305; 8888145043C, 2017500128, 10884521056305; 8888145043C, 2017600093, 10884521056305; 8888145043C, 2026000077, 10884521056305; 8888145043C, 2026000079, 10884521056305; 8888145043C, 2026000080, 10884521056305; 8888145043C, 2026000081, 10884521056305; 8888145043C, 2116200114, 10884521056305; 8888145043C, 2119400127, 10884521056305; 8888145043C, 2125800084, 10884521056305; 8888145043C, 2125800085, 10884521056305; 8888145043C, 2125800086, 10884521056305; 8888145043C, 2125800087, 10884521056305; 8888145043C, 1924600101, 20884521056302; 8888145043C, 1926100282, 20884521056302; 8888145043C, 2002900150, 20884521056302; 8888145043C, 2014900156, 20884521056302; 8888145043C, 2017500125, 20884521056302; 8888145043C, 2017500128, 20884521056302; 8888145043C, 2017600093, 20884521056302; 8888145043C, 2026000077, 20884521056302; 8888145043C, 2026000079, 20884521056302; 8888145043C, 2026000080, 20884521056302; 8888145043C, 2026000081, 20884521056302; 8888145043C, 2116200114, 20884521056302; 8888145043C, 2119400127, 20884521056302; 8888145043C, 2125800086, 20884521056302; 8888145043C, 2125800087, 20884521056302; 8888145043C, 2125800088, 20884521056302; 8888145044C, 1924600102, 10884521056312; 8888145044C, 1926100278, 10884521056312; 8888145044C, 1926100283, 10884521056312; 8888145044C, 1926100284, 10884521056312; 8888145044C, 1928100093, 10884521056312; 8888145044C, 2014900157, 10884521056312; 8888145044C, 2017600094, 10884521056312; 8888145044C, 2023300171, 10884521056312; 8888145044C, 2026000082, 10884521056312; 8888145044C, 2026000083, 10884521056312; 8888145044C, 2026000084, 10884521056312; 8888145044C, 2026000085, 10884521056312; 8888145044C, 2026000086, 10884521056312; 8888145044C, 2026000153, 10884521056312; 8888145044C, 2106900135, 10884521056312; 8888145044C, 2106900213, 10884521056312; 8888145044C, 2108100058, 10884521056312; 8888145044C, 1924600102, 20884521056319; 8888145044C, 1926100278, 20884521056319; 8888145044C, 1926100283, 20884521056319; 8888145044C, 1926100284, 20884521056319; 8888145044C, 1928100093, 20884521056319; 8888145044C, 2014900157, 20884521056319; 8888145044C, 2017600094, 20884521056319; 8888145044C, 2023300171, 20884521056319; 8888145044C, 2026000082, 20884521056319; 8888145044C, 2026000084, 20884521056319; 8888145044C, 2026000085, 20884521056319; 8888145044C, 2026000086, 20884521056319; 8888145044C, 2026000153, 20884521056319; 8888145044C, 2106900135, 20884521056319; 8888145044C, 2106900140, 20884521056319; 8888145044C, 2106900213, 20884521056319; 8888145044C, 2108100058, 20884521056319; 8888145044C, 2120000070, 20884521056319; 8888145045C, 1924600106, 10884521056329; 8888145045C, 1926100279, 10884521056329; 8888145045C, 1926800382, 10884521056329; 8888145045C, 1926800383, 10884521056329; 8888145045C, 2017500126, 10884521056329; 8888145045C, 2026000089, 10884521056329; 8888145045C, 1924600106, 20884521056326; 8888145045C, 1926100279, 20884521056326; 8888145045C, 1926800382, 20884521056326; 8888145045C, 1926800383, 20884521056326; 8888145045C, 2017500126, 20884521056326; 8888145045C, 2026000089, 20884521056326; 8888145045C, 2100500127, 20884521056326; 8888145046C, 2026000091, 10884521056336; 8888145046C, 2026000091, 20884521056333
  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 H Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.

Product Codes/Lot Numbers:

Code Information organized as "Model No., Serial No., GTIN": 8888119365, 1925200097, 20884521012810; 8888119371, 2031800117, 20884521056562; 8888123405, 2028200168, 20884521012940; 8888123405, 2127200428, 20884521012940; 8888145043, 1932200082, 10884521013223; 8888145043, 2003700042, 10884521013223; 8888145043, 2014900147, 10884521013223; 8888145043, 2023300169, 10884521013223; 8888145043, 2031800113, 10884521013223; 8888145043, 2034400185, 10884521013223; 8888145043, 2104600104, 10884521013223; 8888145043, 2108100054, 10884521013223; 8888145043, 2127200539, 10884521013223; 8888145043, 1919700110, 20884521013220; 8888145043, 1929500076, 20884521013220; 8888145043, 1932200082, 20884521013220; 8888145043, 2000700103, 20884521013220; 8888145043, 2003700042, 20884521013220; 8888145043, 2014900147, 20884521013220; 8888145043, 2019200001, 20884521013220; 8888145043, 2023300169, 20884521013220; 8888145043, 2028200174, 20884521013220; 8888145043, 2031800112, 20884521013220; 8888145043, 2031800113, 20884521013220; 8888145043, 2034400185, 20884521013220; 8888145043, 2034400187, 20884521013220; 8888145043, 2104600100, 20884521013220; 8888145043, 2104600104, 20884521013220; 8888145043, 2108100054, 20884521013220; 8888145043, 2108100055, 20884521013220; 8888145043, 2108100056, 20884521013220; 8888145043, 2109700070, 20884521013220; 8888145043, 2116500163, 20884521013220; 8888145043, 2124500119, 20884521013220; 8888145043, 2127200539, 20884521013220; 8888145043, 2127200540, 20884521013220; 8888145043, 2127200541, 20884521013220; 8888145044, 1922500109, 10884521013247; 8888145044, 1922500112, 10884521013247; 8888145044, 1925200063, 10884521013247; 8888145044, 1933700119, 10884521013247; 8888145044, 2000700104, 10884521013247; 8888145044, 2104600101, 10884521013247; 8888145044, 2106900137, 10884521013247; 8888145044, 2110900104, 10884521013247; 8888145044, 2113400084, 10884521013247; 8888145044, 2116200117, 10884521013247; 8888145044, 2200300118, 10884521013247; 8888145044, 1922500109, 20884521013244; 8888145044, 1922500110, 20884521013244; 8888145044, 1922500112, 20884521013244; 8888145044, 1925200063, 20884521013244; 8888145044, 1929500075, 20884521013244; 8888145044, 1929500092, 20884521013244; 8888145044, 1933700119, 20884521013244; 8888145044, 2000700104, 20884521013244; 8888145044, 2104600101, 20884521013244; 8888145044, 2104600102, 20884521013244; 8888145044, 2104900109, 20884521013244; 8888145044, 2106900137, 20884521013244; 8888145044, 2110900104, 20884521013244; 8888145044, 2113300436, 20884521013244; 8888145044, 2113400084, 20884521013244; 8888145044, 2116200115, 20884521013244; 8888145044, 2116200116, 20884521013244; 8888145044, 2116200117, 20884521013244; 8888145044, 2124500106, 20884521013244; 8888145044, 2124500121, 20884521013244; 8888145044, 2200300118, 20884521013244; 8888145045, 1929500093, 10884521017900; 8888145045, 1933700120, 10884521017900; 8888145045, 2004400084, 10884521017900; 8888145045, 2110900143, 10884521017900; 8888145045, 2113400059, 10884521017900; 8888145045, 1822000073, 20884521017907; 8888145045, 1929500093, 20884521017907; 8888145045, 1933700120, 20884521017907; 8888145045, 2004400084, 20884521017907; 8888145045, 2110900143, 20884521017907; 8888145045, 2113400059, 20884521017907; 8888145045, 2124500087, 20884521017907; 8888145046, 1927500059, 20884521013268; 8888145046, 1927500060, 20884521013268; 8888145069, 2017600095, 20884521056708; 8888145070, 2026000154, 20884521056715; 8888145043C, 1924600101, 10884521056305; 8888145043C, 1926100282, 10884521056305; 8888145043C, 2002900150, 10884521056305; 8888145043C, 2014900156, 10884521056305; 8888145043C, 2017500125, 10884521056305; 8888145043C, 2017500128, 10884521056305; 8888145043C, 2017600093, 10884521056305; 8888145043C, 2026000077, 10884521056305; 8888145043C, 2026000079, 10884521056305; 8888145043C, 2026000080, 10884521056305; 8888145043C, 2026000081, 10884521056305; 8888145043C, 2116200114, 10884521056305; 8888145043C, 2119400127, 10884521056305; 8888145043C, 2125800084, 10884521056305; 8888145043C, 2125800085, 10884521056305; 8888145043C, 2125800086, 10884521056305; 8888145043C, 2125800087, 10884521056305; 8888145043C, 1924600101, 20884521056302; 8888145043C, 1926100282, 20884521056302; 8888145043C, 2002900150, 20884521056302; 8888145043C, 2014900156, 20884521056302; 8888145043C, 2017500125, 20884521056302; 8888145043C, 2017500128, 20884521056302; 8888145043C, 2017600093, 20884521056302; 8888145043C, 2026000077, 20884521056302; 8888145043C, 2026000079, 20884521056302; 8888145043C, 2026000080, 20884521056302; 8888145043C, 2026000081, 20884521056302; 8888145043C, 2116200114, 20884521056302; 8888145043C, 2119400127, 20884521056302; 8888145043C, 2125800086, 20884521056302; 8888145043C, 2125800087, 20884521056302; 8888145043C, 2125800088, 20884521056302; 8888145044C, 1924600102, 10884521056312; 8888145044C, 1926100278, 10884521056312; 8888145044C, 1926100283, 10884521056312; 8888145044C, 1926100284, 10884521056312; 8888145044C, 1928100093, 10884521056312; 8888145044C, 2014900157, 10884521056312; 8888145044C, 2017600094, 10884521056312; 8888145044C, 2023300171, 10884521056312; 8888145044C, 2026000082, 10884521056312; 8888145044C, 2026000083, 10884521056312; 8888145044C, 2026000084, 10884521056312; 8888145044C, 2026000085, 10884521056312; 8888145044C, 2026000086, 10884521056312; 8888145044C, 2026000153, 10884521056312; 8888145044C, 2106900135, 10884521056312; 8888145044C, 2106900213, 10884521056312; 8888145044C, 2108100058, 10884521056312; 8888145044C, 1924600102, 20884521056319; 8888145044C, 1926100278, 20884521056319; 8888145044C, 1926100283, 20884521056319; 8888145044C, 1926100284, 20884521056319; 8888145044C, 1928100093, 20884521056319; 8888145044C, 2014900157, 20884521056319; 8888145044C, 2017600094, 20884521056319; 8888145044C, 2023300171, 20884521056319; 8888145044C, 2026000082, 20884521056319; 8888145044C, 2026000084, 20884521056319; 8888145044C, 2026000085, 20884521056319; 8888145044C, 2026000086, 20884521056319; 8888145044C, 2026000153, 20884521056319; 8888145044C, 2106900135, 20884521056319; 8888145044C, 2106900140, 20884521056319; 8888145044C, 2106900213, 20884521056319; 8888145044C, 2108100058, 20884521056319; 8888145044C, 2120000070, 20884521056319; 8888145045C, 1924600106, 10884521056329; 8888145045C, 1926100279, 10884521056329; 8888145045C, 1926800382, 10884521056329; 8888145045C, 1926800383, 10884521056329; 8888145045C, 2017500126, 10884521056329; 8888145045C, 2026000089, 10884521056329; 8888145045C, 1924600106, 20884521056326; 8888145045C, 1926100279, 20884521056326; 8888145045C, 1926800382, 20884521056326; 8888145045C, 1926800383, 20884521056326; 8888145045C, 2017500126, 20884521056326; 8888145045C, 2026000089, 20884521056326; 8888145045C, 2100500127, 20884521056326; 8888145046C, 2026000091, 10884521056336; 8888145046C, 2026000091, 20884521056333

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-1317-2022

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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

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