Home / Recalls / Covidien Llc / Z-1318-2022

Z-1318-2022 Class I Ongoing

Recalled by Covidien Llc — Mansfield, MA

FDA device recall Z-1318-2022 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: 2,462 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: 2,462 units

Product Description

Palindrome SI 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": 8888119368, 1925200090, 20884521012841; 8888119368, 1933700094, 20884521012841; 8888119368, 2001400077, 20884521012841; 8888119368, 2026000056, 20884521012841; 8888123408, 2009400114, 20884521012957; 8888128458, 1935100068, 20884521013039; 8888133508, 2026000060, 20884521013107; 8888145062, 2031800153, 10884521013407; 8888145062, 1933700095, 20884521013404; 8888145062, 2009400116, 20884521013404; 8888145062, 2031800131, 20884521013404; 8888145062, 2031800153, 20884521013404; 8888145063, 2000700056, 20884521013428; 8888145063, 2009400113, 20884521013428; 8888145063, 2027200181, 20884521013428; 8888145064, 2030100077, 20884521013442; 8888145065, 2026000067, 20884521013466; 8888145066, 2011900104, 10884521013476; 8888145066, 2019500162, 10884521013476; 8888145066, 2011900104, 20884521013473; 8888145066, 2019500162, 20884521013473

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-1318-2022
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.

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