CLASS I ONGOING Device recall · Reported 13 Jul 2022 · FDA Enforcement Report
Palindrome HSI Chronic Catheter, Sterile, Single Use recalled
Covidien is recalling Palindrome HSI Chronic Catheter, Sterile, Single Use, distributed nationwide in the US. The recall was initiated on 8 Jun 2022 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1319-2022
- FDA event ID
- 90311
- Recalling firm
- Covidien, Mansfield, MA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 8 Jun 2022
- FDA classified
- 7 Jul 2022
- Reported
- 13 Jul 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Device type
- Heart & Vascular Devices
Timeline
| 8 Jun 2022 | Recall initiated by company | |
| 7 Jul 2022 | Classified by FDA | +29 days |
| 13 Jul 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Palindrome HSI Chronic Catheter, Sterile, Single Use, Rx Only. For acute and chronic hemodialysis, apheresis, and infusion.
Where it was distributed
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.
Nationwide AlaskaAlabamaArkansasArizonaCaliforniaColoradoConnecticutDistrict of ColumbiaDelawareFloridaGeorgiaHawaiiIowaIdahoIllinoisIndianaKansasKentuckyLouisianaMassachusetts
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
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
Where was it sold?
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.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 90311This product is part of a recall event; the main page for the event is Palindrome Precision Chronic Catheter, Sterile, Single Use recalled.
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