FDA Device recall Z-1318-2022
Palindrome SI 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 SI 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-1318-2022 |
| 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 SI 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": 8888119368, 1925200090, 20884521012841; 8888119368, 193370…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 |
|---|
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-1318-2022%22
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