Medcomp Duo-Flow 400XL Catheter — Class II medical device recall Z-1351-2015
Terminated recall by Medical Components, Inc dba MedComp, reported 2015-04-08. Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen In
| Recall number | Z-1351-2015 |
|---|---|
| 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 | 2015-02-05 |
| Classified | 2015-03-30 |
| Reported by FDA | 2015-04-08 |
| Terminated | 2015-08-06 |
| Quantity | 3,152 |
| Reason classes | specification failure |
| Lot numbers | 10301207/MGMD930, 10800701/MGLY730, 10800702/MGMD210, 10800703/MGLY740, DFXL148MTE, HFS24E./MGLY830, MC061402/MGMD190, MC3L-8S/MGMD920, MGMB440, MGMC610, MR17035211/MGMD680 |
Product
Medcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.
Reason for recall
Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.
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-1351-2015. 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.