—#194332

Product

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

FDA product code: MSD — Catheter, Hemodialysis, Implanted
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K112477
Affected lot / code info: 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

Why it was 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.

Root cause (FDA determination)

Process control

Action the firm took

Medtronic distributed a recall notification to customers by mail on 06/08/2022. Customers were instructed to immediately quarantine and discontinue use for specific lots of chronic hemodialysis catheters, which are to be returned to Medtronic. If customers have further distributed product, they are asked to forward the information from the recall notification to those recipients. All customers are asked to complete and return the Consignee Product Retrieval Confirmation Form to rs.gmbfcamitg@medtronic.com. Additionally, consignees are asked to share the notice within their organization and retain it for their records regarding the retrieval of unused product. If a consignee is aware of any adverse events associated with recalled product, they are to submit a report to FDA via Medwatch. Customers with any questions can contact their Medtronic Representative or call Customer Service at 800-962-9888, option 2. ***Updated 8/16/22*** Medtronic has created a website to help customers identify affected product: https://www.medtronic.com/covidien/en-us/products/c/renal-care-recall-lookup-tool.html#lotLookupTool

Recalling firm

Firm: Covidien Llc
Address: 15 Hampshire St, Mansfield, Massachusetts 02048-1113

Distribution

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.

Timeline

Recall initiated: 2022-06-08
Posted by FDA: 2022-07-07
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #194332. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.