Data Foundry

Medical device recalls 2023

MAHURKAR 13 — Class I medical device recall Z-0877-2023

Ongoing recall by Covidien LP, reported 2023-01-18, distributed nationwide. There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the h

Recall numberZ-0877-2023
Product typeMedical device
ClassificationClass I
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCovidien LP, Mansfield, MA, United States
Recall initiated2022-12-07
Classified2023-01-12
Reported by FDA2023-01-18
DistributedNationwide (US)
Countries outside the USAE, AT, AU, BE, BR, CA, CH, CL, CN, CO, CR, CZ, DE, DK, DO, EC, ES, FI, FR, GB, GR, HU, IS, IT, JM, KE, MT, MX, MY, NI, NO, OM, PA, PE, PH, PL, PT, RO, SA, SE, SK, TH, TN, TR, TT, TW, ZA
Reason classespackaging
UPC / GTIN / UDI-DI10884521057364, 20884521006208, 20884521006215, 20884521006253, 20884521006284, 20884521006352, 20884521006376, 20884521006383, 20884521006406, 20884521006444, 20884521006475, 20884521006499, 20884521006505, 20884521006536, 20884521006543, 20884521006550
Lot numbers1800300109, 1800300110, 1801000105, 1801000106, 1801600120, 1801600121, 1802300087, 1802300089, 1802300090, 1802300094, 1803100140, 1803700085, 1803700086, 1804500111, 1804500112, 1805100083, 1805100084, 1805100085, 1805800137, 1805800138, 1806500173, 1806500174, 1806500175, 1806500176, 1806500177, 1807300109, 1807300110, 1807300111, 1807900111, 1807900112, 1807900113, 1807900115, 1808200161, 1808500121, 1808500122, 1808500123, 1808500124, 1809200136, 1809200137, 1809200138 and 460 more
Serial numbers1800300109, 1800300110, 1801000105, 1801000106, 1801600120, 1801600121, 1802300087, 1802300089, 1802300090, 1802300094, 1803100140, 1803700085, 1803700086, 1804500111, 1804500112, 1805100083, 1805100084, 1805100085, 1805800137, 1805800138, 1806500173, 1806500174, 1806500175, 1806500176, 1806500177 and 475 more
Model numbers8888135131, 8888135132, 8888135133, 8888135134, 8888135161, 8888135162, 8888135163, 8888135164, 8888135191, 8888135192, 8888135193, 8888135194, 8888135198, 8888135241, 8888135242, 8888135243

Product

MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8888135132; 13.5cm, Pre-Curved, Kit - Model No. 8888135133; 13.5cm, Straight Extensions, IC Tray, Model No. 8888135134; 16cm, Straight Extensions, Kit - Model No. 8888135161; 16cm, Curved Extensions, Kit - Model No. 8888135162; 16 cm, Pre-Curved, Kit - Model No. 8888135163; 16cm, Straight Extensions, IC Tray - Model No. 8888135164; 19.5cm, Straight Extensions, Kit - Model No. 8888135191; 19.5cm, Curved Extensions, Kit - Model No. 8888135192; 19.5cm, Pre-Curved, Kit - Model No. 8888135193; 19.5cm, Straight Extensions, IC Tray - Model No. 8888135194; 19.5cm, Curved Extensions, PASS Tray - Model No. 8888135198; 24cm, Straight Extensions, Kit - Model No. 8888135241; 24cm, Curved Extensions, Kit - Model No. 8888135242; 24cm, Pre-Curved, Kit - Model No. 8888135243

Reason for recall

There is a potential leaking condition within the hub of affected devices, 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-0877-2023. 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.