Data Foundry

Medical device recalls 2023

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter — Class I medical device recall Z-2388-2023

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 numberZ-2388-2023
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCovidien LP, Mansfield, MA, United States
Recall initiated2023-06-28
Classified2023-08-11
Reported by FDA2023-08-23
DistributedNationwide (US)
Countries outside the USAE, 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
Quantity6,949 units
Reason classesspecification failure, device malfunction
UPC / GTIN / UDI-DI10884521006799
Lot numbers2009400128, 2113300290, 2116500142, 2116500176, 2119400221, 2119400227, 2122900119, 2122900127, 2122900216, 2122900231, 2127300111, 2127300113
Model numbers8888345629

Product

MAHURKAR 12 Fr Triple Lumen Acute Dialysis Catheter, 20 cm, Curved Extensions, Kit" REF: 8888345629

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-2388-2023. 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.