MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter — Class II medical device recall Z-2535-2015
Terminated recall by Covidien LLC, reported 2015-09-09, distributed nationwide. Sterility may be compromised
| Recall number | Z-2535-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LLC, North Haven, CT, United States |
| Recall initiated | 2015-08-06 |
| Classified | 2015-09-01 |
| Reported by FDA | 2015-09-09 |
| Terminated | 2017-06-29 |
| Distributed | Nationwide (US) |
| Quantity | 569 kits |
| Reason classes | sterility |
| Lot numbers | 1504700146 |
| Model numbers | 8888103002HP |
Product
MAHURKAR 12Fr High Pressure Triple Lumen Acute Dialysis Catheter, 16cm, Curved Extensions, PASS Tray Item Code: 8888103002HP Product Usage: Sterile Delivery are indicated for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.
Reason for recall
Sterility may be compromised
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-2535-2015. 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.