Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access for ac...
FDA Device Recall #Z-1313-2022 — Class I — June 8, 2022
Recall Summary
| Recall Number | Z-1313-2022 |
| Classification | Class I — Serious risk |
| Date Initiated | June 8, 2022 |
| Status | Ongoing |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Covidien Llc |
| Location | Mansfield, MA |
| Product Type | Devices |
| Quantity | 26,675 units |
Product Description
Palindrome Precision H Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access 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.
Lot / Code Information
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
Other Recalls from Covidien Llc
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1557-2026 | Class II | HealthCast "Vital Sync" Remote Patient Monitori... | Jan 30, 2026 |
| Z-1775-2022 | Class II | Puritan Bennett 560 Ventilator, PB560, CFN 4096600 | Aug 19, 2022 |
| Z-1318-2022 | Class I | Palindrome SI Chronic Catheter, Sterile, Single... | Jun 8, 2022 |
| Z-1319-2022 | Class I | Palindrome HSI Chronic Catheter, Sterile, Singl... | Jun 8, 2022 |
| Z-1315-2022 | Class I | Palindrome Precision HSI Chronic Catheter, Ster... | Jun 8, 2022 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.