FDA Device recall Z-1312-2022
Palindrome Precision 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 Precision 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-1312-2022 |
| 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 Precision 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": 8888123400, 1729700111, 20884521012933; 8888123400, 183100…Code Information organized as "Model No., Serial No., GTIN": 8888123400, 1729700111, 20884521012933; 8888123400, 1831000130, 20884521012933; 8888123400, 1904600085, 20884521012933; 8888133500, 2012100128, 20884521013060; 8888119360P, 2007800129, 10884521157699; 8888119360P, 2034400078, 10884521157699; 8888119360P, 1720000102, 20884521157696; 8888119360P, 1904200103, 20884521157696; 8888119360P, 1923400228, 20884521157696; 8888119360P, 1932300203, 20884521157696; 8888119360P, 2007800129, 20884521157696; 8888119360P, 2034400078, 20884521157696; 8888119360P, 2104600179, 20884521157696; 8888119360P, 2110900110, 20884521157696; 8888119360P, 2113300438, 20884521157696; 8888119360P, 2127700068, 20884521157696; 8888119364P, 1925200093, 10884521157705; 8888119364P, 1934400186, 10884521157705; 8888119364P, 2019500171, 10884521157705; 8888119364P, 2020400088, 10884521157705; 8888119364P, 2028200217, 10884521157705; 8888119364P, 2034400079, 10884521157705; 8888119364P, 2034400115, 10884521157705; |
|---|
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-1312-2022%22
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