Recall archive / FDA device enforcement
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and inf... — FDA record Z-1319-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Jun 8, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
- Reason
- 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
- Recalling firm
- Covidien Llc
- Quantity
- 13,526 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1319-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Code Information organized as "Model No., Serial No., GTIN": 8888119369, 2009300138, 10884521012875; 8888119369, 1935100070, 20884521012872; 8888119369, 2009300138, 20884521012872; 8888119369, 2026000146, 20884521012872; 8888119369, 2028200160, 20884521012872; 8888123409, 2000700062, 10884521012967; 8888123409, 2000700062, 20884521012964; 8888123409, 2001400081, 20884521012964; 8888123409, 2009400112, 20884521012964; 8888128459, 2127200434, 10884521013049; 8888128459, 2127200434, 20884521013046; 8888133509, 2026000147, 20884521013114; 8888145048, 2005600027, 10884521013278; 8888145048, 2009400106, 10884521013278; 8888145048, 2012100182, 10884521013278; 8888145048, 2012100188, 10884521013278; 8888145048, 2014900141, 10884521013278; 8888145048, 2028200161, 10884521013278; 8888145048, 2028200170, 10884521013278; 8888145048, 2031800114, 10884521013278; 8888145048, 2104900105, 10884521013278; 8888145048, 2110900138, 10884521013278; 8888145048, 2110900139, 10884521013278; 8888145048, 2005600027, 20884521013275; 8888145048, 2009400106, 20884521013275; 8888145048, 2012100182, 20884521013275; 8888145048, 2012100188, 20884521013275; 8888145048, 2028200161, 20884521013275; 8888145048, 2028200170, 20884521013275; 8888145048, 2031800114, 20884521013275; 8888145048, 2104900105, 20884521013275; 8888145048, 2110900138, 20884521013275; 8888145048, 2110900139, 20884521013275; 8888145049, 1915800111, 10884521017818; 8888145049, 2001400080, 10884521017818; 8888145049, 2012100183, 10884521017818; 8888145049, 2012100189, 10884521017818; 8888145049, 2014900142, 10884521017818; 8888145049, 2116200121, 10884521017818; 8888145049, 1915800111, 20884521017815; 8888145049, 2001400080, 20884521017815; 8888145049, 2012100183, 20884521017815; 8888145049, 2012100189, 20884521017815; 8888145049, 2014900142, 20884521017815; 8888145049, 2116200121, 20884521017815; 8888145050, 1915800081, 10884521013292; 8888145050, 2009300126, 10884521013292; 8888145050, 1915800081, 20884521013299; 8888145050, 1935100071, 20884521013299; 8888145050, 2009300088, 20884521013299; 8888145050, 2009300126, 20884521013299; 8888145057, 1933000053, 10884521013315; 8888145057, 1933000054, 10884521013315; 8888145057, 2002100110, 10884521013315; 8888145057, 2005600029, 10884521013315; 8888145057, 2005600030, 10884521013315; 8888145057, 2005600031, 10884521013315; 8888145057, 2009200095, 10884521013315; 8888145057, 2012100185, 10884521013315; 8888145057, 2014900140, 10884521013315; 8888145057, 2014900144, 10884521013315; 8888145057, 2028200158, 10884521013315; 8888145057, 2028200182, 10884521013315; 8888145057, 2031800115, 10884521013315; 8888145057, 2106900154, 10884521013315; 8888145057, 2124500110, 10884521013315; 8888145057, 1933000053, 20884521013312; 8888145057, 1933000054, 20884521013312; 8888145057, 1933700090, 20884521013312; 8888145057, 2002100110, 20884521013312; 8888145057, 2002900095, 20884521013312; 8888145057, 2005600029, 20884521013312; 8888145057, 2005600030, 20884521013312; 8888145057, 2005600031, 20884521013312; 8888145057, 2009200095, 20884521013312; 8888145057, 2009200096, 20884521013312; 8888145057, 2012100185, 20884521013312; 8888145057, 2014900140, 20884521013312; 8888145057, 2014900144, 20884521013312; 8888145057, 2028200158, 20884521013312; 8888145057, 2028200182, 20884521013312; 8888145057, 2031800115, 20884521013312; 8888145057, 2106900154, 20884521013312; 8888145057, 2124500110, 20884521013312; 8888145048C, 1924600107, 20884521083049; 8888145048C, 1927300067, 20884521083049; 8888145048C, 2026000155, 20884521083049; 8888145049C, 2018100027, 20884521083056; 8888145050C, 1926100281, 10884521083066; 8888145050C, 1926100281, 20884521083063; 8888145057C, 1927500052, 10884521083073; 8888145057C, 1927500052, 20884521083070; 8888145057C, 2026000161, 20884521083070 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution - US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY, DC, GU, & PR. The countries of Argentina, Australia, Austria, Bahamas, Bahrain, Bangladesh, Belgium, Botswana, Brazil, Brunei Darussalam, Bulgaria, Cambodia, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Dominican Republic, Ecuador, Egypt, El Salvador, Estonia, Faroe Islands, Finland, France, French Guiana, French Polynesia, Georgia, Germany, Ghana, Greece, Guatemala, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Islamic Republic of Iran, Ireland, Israel, Italy, Jamaica, Japan, Kenya, Republic of Korea, Kosovo, Kuwait, Lebanon, Luxembourg, Macao, Malaysia, Maldives, Malta, Mayotte, Mexico, Myanmar, Namibia, Nepal, Netherlands, New Zealand, Nicaragua, North Macedonia, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, San Marino, Saudi Arabia, Senegal, Singapore, Slovakia, South Africa, Spain, Sweden, Switzerland, Syrian Arab Republic, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, United Arab Emirates, United Kingdom, United States, Viet Nam, Virgin Islands, and Zimbabwe.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Jul 13, 2022
- Recall initiation date
- Jun 8, 2022
- Center classification date
- Jul 7, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.