Palindrome Precision Chronic Catheter — Class I medical device recall Z-1312-2022
Ongoing recall by Covidien Llc, reported 2022-07-13, distributed nationwide. There is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-
| Recall number | Z-1312-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien Llc, Mansfield, MA, United States |
| Recall initiated | 2022-06-08 |
| Classified | 2022-07-07 |
| Reported by FDA | 2022-07-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, AU, BD, BE, BG, BH, BR, BS, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, EE, EG, ES, FI, FR, GB, GH, GR, GT, HK, HN, HR, HU, ID, IE, IL, IN, IR, IS, IT, JM, JP, KE, KR, KW, LB, LU, MT, MX, MY, NI, NL, NO, NP, NZ, OM, PA, PE, PH, PK, PL, PT, PY, QA, RO, SA, SE, SG, SK, SV, TH, TN, TR, TT, TW, VN, ZA |
| Quantity | 213,589 units |
| Reason classes | packaging |
| UPC / GTIN / UDI-DI | 10884521157699, 10884521157705, 10884521157774, 10884521157811, 10884521157842, 10884521157910, 10884521157972, 10884521157989, 10884521157996, 10884521158009, 10884521158016, 10884521158023, 10884521158030, 10884521158047, 10884521158054, 10884521158283, 10884521158290, 10884521158306, 10884521158467, 20884521012933, 20884521013060, 20884521157696, 20884521157702, 20884521157740, 20884521157764 and 22 more |
Product
Palindrome Precision Chronic Catheter, Sterile, Single Use, Rx Only. For vascular access 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1312-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.