Z-1313-2022Class I

Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and...

Name: Z-1313-2022 Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and...
Creator: Covidien Llc
Published: 2022-06-08
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2022-06-08 / Open, Classified / root cause: manufacturing process

FDA source

Covidien Llc began a recall of Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion on 2022-06-08. FDA classified it as Class I and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1313-2022
Classification: Class I
Status: Open, Classified
Initiated: 2022-06-08
Posted: 2022-07-07
Recalling firm: Medtronic, Inc.
Product: Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for acute and chronic hemodialysis, apheresis, and infusion.
Product code: MSD Catheter, Hemodialysis, Implanted
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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 [email protected]. 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
Quantity in commerce: 26,675 units
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.
Product codes and lots: Code Information organized as "Model No., Serial No., GTIN": 8888119365P, 2119400168, 10884521157712; 8888119365P, 1923400245, 20884521157719; 8888119365P, 1923400268, 20884521157719; 8888119365P, 1935100114, 20884521157719; 8888119365P, 2002100145, 20884521157719; 8888119365P, 2002900148, 20884521157719; 8888119365P, 2020400090, 20884521157719; 8888119365P, 2023300173, 20884521157719; 8888119365P, 2026000162, 20884521157719; 8888119365P, 2031800126, 20884521157719; 8888119365P, 2034400186, 20884521157719; 8888119365P, 2104600103, 20884521157719; 8888119365P, 2104600233, 20884521157719; 8888119365P, 2108100057, 20884521157719; 8888119365P, 2116500094, 20884521157719; 8888119365P, 2116500095, 20884521157719; 8888119365P, 2119400168, 20884521157719; 8888119371P, 1935100115, 10884521157750; 8888123405P, 2002100146, 10884521157781; 8888123405P, 2014900155, 10884521157781; 8888123405P, 2104600162, 10884521157781; 8888123405P, 1924000136, 20884521157788; 8888123405P, 1924000157, 20884521157788; 8888123405P, 1927300064, 20884521157788; 8888123405P, 1928800238, 20884521157788; 8888123405P, 2002100146, 20884521157788; 8888123405P, 2014900155, 20884521157788; 8888123405P, 2023300174, 20884521157788; 8888123405P, 2026000173, 20884521157788; 8888123405P, 2028200162, 20884521157788; 8888123405P, 2104600162, 20884521157788; 8888123405P, 2106900134, 20884521157788; 8888123405P, 2115800062, 20884521157788; 8888123405P, 2115800093, 20884521157788; 8888123405P, 2119400133, 20884521157788; 8888123411P, 2119400128, 20884521157825; 8888128455P, 2002100148, 10884521157859; 8888128455P, 1924000181, 20884521157856; 8888128455P, 1927300066, 20884521157856; 8888128455P, 2002100148, 20884521157856; 8888128455P, 2104600164, 20884521157856; 8888128455P, 2127200433, 20884521157856; 8888128461P, 2012100186, 20884521157894; 8888133505P, 1924600127, 20884521157924; 8888145043CP, 1927500054, 10884521158061; 8888145043CP, 2021000087, 10884521158061; 8888145043CP, 2026000094, 10884521158061; 8888145043CP, 2026000166, 10884521158061; 8888145043CP, 2120000069, 10884521158061; 8888145043CP, 1927500053, 20884521158068; 8888145043CP, 1927500054, 20884521158068; 8888145043CP, 2021000087, 20884521158068; 8888145043CP, 2026000093, 20884521158068; 8888145043CP, 2026000094, 20884521158068; 8888145043CP, 2026000166, 20884521158068; 8888145043CP, 2028200155, 20884521158068; 8888145043CP, 2115800061, 20884521158068; 8888145043CP, 2120000069, 20884521158068; 8888145043P, 1917200199, 10884521158078; 8888145043P, 1917200200, 10884521158078; 8888145043P, 1917200201, 10884521158078; 8888145043P, 1917200280, 10884521158078; 8888145043P, 1917200281, 10884521158078; 8888145043P, 1917600109, 10884521158078; 8888145043P, 1917600110, 10884521158078; 8888145043P, 2028200184, 10884521158078; 8888145043P, 2028200227, 10884521158078; 8888145043P, 1917200199, 20884521158075; 8888145043P, 1917200200, 20884521158075; 8888145043P, 1917200201, 20884521158075; 8888145043P, 1917200280, 20884521158075; 8888145043P, 1917200281, 20884521158075; 8888145043P, 1917600109, 20884521158075; 8888145043P, 1917600110, 20884521158075; 8888145043P, 1921300033, 20884521158075; 8888145043P, 1921900180, 20884521158075; 8888145043P, 2028200184, 20884521158075; 8888145043P, 2028200227, 20884521158075; 8888145044CP, 1907800083, 10884521158085; 8888145044CP, 1927500061, 10884521158085; 8888145044CP, 1927500062, 10884521158085; 8888145044CP, 2023300154, 10884521158085; 8888145044CP, 2026000123, 10884521158085; 8888145044CP, 2026000124, 10884521158085; 8888145044CP, 2026000125, 10884521158085; 8888145044CP, 2026000169, 10884521158085; 8888145044CP, 2119400129, 10884521158085; 8888145044CP, 2119400144, 10884521158085; 8888145044CP, 2125800093, 10884521158085; 8888145044CP, 1907800083, 20884521158082; 8888145044CP, 1927500061, 20884521158082; 8888145044CP, 1927500062, 20884521158082; 8888145044CP, 1929400083, 20884521158082; 8888145044CP, 2014900162, 20884521158082; 8888145044CP, 2023300154, 20884521158082; 8888145044CP, 2026000123, 20884521158082; 8888145044CP, 2026000124, 20884521158082; 8888145044CP, 2026000125, 20884521158082; 8888145044CP, 2026000132, 20884521158082; 8888145044CP, 2026000169, 20884521158082; 8888145044CP, 2119400129, 20884521158082; 8888145044CP, 2119400144, 20884521158082; 8888145044CP, 2125800093, 20884521158082; 8888145044P, 1917600112, 10884521158092; 8888145044P, 1917600113, 10884521158092; 8888145044P, 1917600114, 10884521158092; 8888145044P, 1917600115, 10884521158092; 8888145044P, 1917600135, 10884521158092; 8888145044P, 2023300137, 10884521158092; 8888145044P, 2026000174, 10884521158092; 8888145044P, 2028200164, 10884521158092; 8888145044P, 2028200187, 10884521158092; 8888145044P, 2106900214, 10884521158092; 8888145044P, 2106900227, 10884521158092; 8888145044P, 2124500093, 10884521158092; 8888145044P, 1917600112, 20884521158099; 8888145044P, 1917600113, 20884521158099; 8888145044P, 1917600114, 20884521158099; 8888145044P, 1917600115, 20884521158099; 8888145044P, 1917600135, 20884521158099; 8888145044P, 2023300137, 20884521158099; 8888145044P, 2026000174, 20884521158099; 8888145044P, 2028200164, 20884521158099; 8888145044P, 2028200187, 20884521158099; 8888145044P, 2106900214, 20884521158099; 8888145044P, 2106900227, 20884521158099; 8888145044P, 2124500093, 20884521158099; 8888145045CP, 1929400084, 10884521158108; 8888145045CP, 1929400085, 10884521158108; 8888145045CP, 2026000133, 10884521158108; 8888145045CP, 1929400084, 20884521158105; 8888145045CP, 1929400085, 20884521158105; 8888145045CP, 2026000133, 20884521158105; 8888145045CP, 2028200166, 20884521158105; 8888145045CP, 2119400136, 20884521158105; 8888145045CP, 2119400195, 20884521158105; 8888145045P, 1917200197, 10884521158115; 8888145045P, 1917200198, 10884521158115; 8888145045P, 2028200169, 10884521158115; 8888145045P, 2115800087, 10884521158115; 8888145045P, 2115800088, 10884521158115; 8888145045P, 1917200197, 20884521158112; 8888145045P, 1917200198, 20884521158112; 8888145045P, 2028200169, 20884521158112; 8888145045P, 2115800087, 20884521158112; 8888145045P, 2115800088, 20884521158112; 8888145046CP, 1924600100, 10884521158122; 8888145046CP, 1924600100, 20884521158129; 8888145046CP, 1926100280, 20884521158129; 8888145046CP, 1926800384, 20884521158129; 8888145046CP, 1929400094, 20884521158129; 8888145046CP, 2026000139, 20884521158129; 8888145046CP, 2028200167, 20884521158129; 8888145046P, 1916500094, 10884521158139; 8888145046P, 1916500095, 10884521158139; 8888145046P, 1920500226, 10884521158139; 8888145046P, 1921300030, 10884521158139; 8888145046P, 1916500094, 20884521158136; 8888145046P, 1916500095, 20884521158136; 8888145046P, 1921300030, 20884521158136; 8888145068P, 1934400183, 20884521158426; 8888145069P, 2104600231, 20884521158433; 8888145070P, 2026000172, 20884521158440; 8888145071P, 1922100139, 20884521158457

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1313-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1312-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07
Z-1313-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07
Z-1314-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07
Z-1315-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07
Z-1316-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07
Z-1317-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07
Z-1318-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07
Z-1319-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07
Z-1320-2022	Class I	Ongoing	Voluntary: Firm initiated	2022-07-13	2022-07-07

Product code MSD

K123196Class IIPalindrome Precision H Chronic Catheter, Palindrome Precision Si Chronic Catheter, Palindrome Precision Hsi Chronic CathCovidien / cleared 2013-01-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)