MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter — Class I medical device recall Z-2385-2023
Ongoing recall by Covidien LP, reported 2023-08-23, distributed nationwide. Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion a
| Recall number | Z-2385-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Covidien LP, Mansfield, MA, United States |
| Recall initiated | 2023-06-28 |
| Classified | 2023-08-11 |
| Reported by FDA | 2023-08-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AR, AT, BD, BE, BH, BR, CA, CH, CN, CR, CZ, DE, DK, DO, ES, FI, FR, GB, GR, HU, IE, IN, IR, IT, KW, KY, LK, MX, MY, NI, NL, NO, NP, PH, PL, PT, SA, SE, SG, SK, TH, TR, ZA |
| Quantity | 2,685 units |
| Reason classes | specification failure, device malfunction |
| UPC / GTIN / UDI-DI | 20884521128139 |
| Lot numbers | 2017400081, 2028300087, 2113300282, 2133700046, 2227800105 |
| Model numbers | 8888345603HP |
Product
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, Kit REF: 8888345603HP
Reason for recall
Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter tip. An occluded, partially or fully, and/or uncured or excessive MDX may dislodge from the catheter lead to full catheter obstruction resulting in delay to treatment and partial obstruction resulting in reduced flow, or particulate dislodgement that may result in delay to treatment, hemolysis, embolism/embolus or thrombosis/thrombus
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-2385-2023. 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.