REPAIR KIT — Class II medical device recall Z-1127-2018
Terminated recall by Medical Components, Inc dba MedComp, reported 2018-03-28, distributed nationwide. There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubin
| Recall number | Z-1127-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Medical Components, Inc dba MedComp, Harleysville, PA, United States |
| Recall initiated | 2018-02-23 |
| Classified | 2018-03-19 |
| Reported by FDA | 2018-03-28 |
| Terminated | 2020-01-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, CA, DE, EC, ES, FR, GB, GR, IE, IL, IT, NL, SE, TR, ZA |
| Quantity | 1,575 kits |
| UPC / GTIN / UDI-DI | 00884908039856 |
| Lot numbers | MCCA800, MCCC310, MCCC320, MCCL340, MCDD250, MCDD640, MCDP460, MCFA160, MCFC040, MCFH990, MCFS390, MCFW690, MKAB730 |
| Model numbers | RPK-01 |
Product
REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable extension tubing.
Reason for recall
There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
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-1127-2018. 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.