FDA Device recall Z-1317-2022

Palindrome H 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 H 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-1317-2022
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 H Chronic Catheter, Sterile, Single Use, Rx Only. 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": 8888119365, 1925200097, 20884521012810; 8888119371, 203180… Code Information organized as "Model No., Serial No., GTIN": 8888119365, 1925200097, 20884521012810; 8888119371, 2031800117, 20884521056562; 8888123405, 2028200168, 20884521012940; 8888123405, 2127200428, 20884521012940; 8888145043, 1932200082, 10884521013223; 8888145043, 2003700042, 10884521013223; 8888145043, 2014900147, 10884521013223; 8888145043, 2023300169, 10884521013223; 8888145043, 2031800113, 10884521013223; 8888145043, 2034400185, 10884521013223; 8888145043, 2104600104, 10884521013223; 8888145043, 2108100054, 10884521013223; 8888145043, 2127200539, 10884521013223; 8888145043, 1919700110, 20884521013220; 8888145043, 1929500076, 20884521013220; 8888145043, 1932200082, 20884521013220; 8888145043, 2000700103, 20884521013220; 8888145043, 2003700042, 20884521013220; 8888145043, 2014900147, 20884521013220; 8888145043, 2019200001, 20884521013220; 8888145043, 2023300169, 20884521013220; 8888145043, 2028200174, 20884521013220; 8888145043, 2031800112, 20884521013220; 8888145043, 2031800

code_info

Code Information organized as "Model No., Serial No., GTIN": 8888119365, 1925200097, 20884521012810; 8888119371, 203180…

Code Information organized as "Model No., Serial No., GTIN": 8888119365, 1925200097, 20884521012810; 8888119371, 2031800117, 20884521056562; 8888123405, 2028200168, 20884521012940; 8888123405, 2127200428, 20884521012940; 8888145043, 1932200082, 10884521013223; 8888145043, 2003700042, 10884521013223; 8888145043, 2014900147, 10884521013223; 8888145043, 2023300169, 10884521013223; 8888145043, 2031800113, 10884521013223; 8888145043, 2034400185, 10884521013223; 8888145043, 2104600104, 10884521013223; 8888145043, 2108100054, 10884521013223; 8888145043, 2127200539, 10884521013223; 8888145043, 1919700110, 20884521013220; 8888145043, 1929500076, 20884521013220; 8888145043, 1932200082, 20884521013220; 8888145043, 2000700103, 20884521013220; 8888145043, 2003700042, 20884521013220; 8888145043, 2014900147, 20884521013220; 8888145043, 2019200001, 20884521013220; 8888145043, 2023300169, 20884521013220; 8888145043, 2028200174, 20884521013220; 8888145043, 2031800112, 20884521013220; 8888145043, 2031800

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-1317-2022%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.