FDA Device recall Z-1316-2022

Palindrome Chronic Catheter, Sterile, Single Use, Rx Only

FDA Device
Class I
ongoing
Published 2022-07-13

On 2022-07-13 the FDA classified a Class I recall of Palindrome Chronic Catheter, Sterile, Single Use, Rx Only by Covidien, citing 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 fl….

Read the official FDA Device notice

Agency	FDA Device
Recall number	Z-1316-2022
Classification	Class I
Status	ongoing
Initiated	2022-06-08
Published	2022-07-13
Last updated	2026-09-13 11:56 UTC
Company	Covidien
Distribution	US

Product

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

Reason

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.

Identifiers

code_info	Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 183100… Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 1831000099, 20884521056555; 8888119364, 1832300114, 20884521056555; 8888119364, 2019500276, 20884521056555; 8888119364, 2106900226, 20884521056555; 8888123404, 1912600108, 20884521056586; 8888123404, 1934400172, 20884521056586; 8888123404, 2012100136, 20884521056586; 8888123404, 2017500130, 20884521056586; 8888123404, 2034400075, 20884521056586; 8888123404, 2104600236, 20884521056586; 8888123404, 2125800094, 20884521056586; 8888123404, 2127200415, 20884521056586; 8888123410, 2019500253, 20884521012988; 8888123410, 2104100079, 20884521012988; 8888128450, 2127200431, 20884521013008; 8888128454, 2017800061, 10884521056619; 8888128454, 1822600121, 20884521056616; 8888128454, 2017800061, 20884521056616; 8888128460, 2019500266, 20884521013053; 8888145014, 1715100153, 10884521013148; 8888145014, 1715800117, 10884521013148; 8888145014, 1715900177, 10884521013148; 8888145014, 1716100

code_info

Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 183100…

Code Information organized as "Model No., Serial No., GTIN": 8888119360, 1916500132, 20884521012803; 8888119364, 1831000099, 20884521056555; 8888119364, 1832300114, 20884521056555; 8888119364, 2019500276, 20884521056555; 8888119364, 2106900226, 20884521056555; 8888123404, 1912600108, 20884521056586; 8888123404, 1934400172, 20884521056586; 8888123404, 2012100136, 20884521056586; 8888123404, 2017500130, 20884521056586; 8888123404, 2034400075, 20884521056586; 8888123404, 2104600236, 20884521056586; 8888123404, 2125800094, 20884521056586; 8888123404, 2127200415, 20884521056586; 8888123410, 2019500253, 20884521012988; 8888123410, 2104100079, 20884521012988; 8888128450, 2127200431, 20884521013008; 8888128454, 2017800061, 10884521056619; 8888128454, 1822600121, 20884521056616; 8888128454, 2017800061, 20884521056616; 8888128460, 2019500266, 20884521013053; 8888145014, 1715100153, 10884521013148; 8888145014, 1715800117, 10884521013148; 8888145014, 1715900177, 10884521013148; 8888145014, 1716100

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1316-2022%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.