Z-1319-2022 Class I Ongoing
Recalled by Covidien Llc
— Mansfield, MA
FDA device recall Z-1319-2022 was initiated by Covidien Llc on Jun 8, 2022 and is designated Class I. 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… The recall status is ongoing. Affected quantity: 13,526 units.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 13, 2022
- Initiation Date
- Jun 8, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,526 units
Product Description
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
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.
Distribution Pattern
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.
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1319-2022
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026
These dates say when openFDA published the data file and when RegDataLab last loaded it. FDA may have changed the recall since.