Double Lumen CRRT/ABP Catheter Set — Class II medical device recall Z-2933-2018
Terminated recall by Medical Components, Inc dba MedComp, reported 2018-09-05, distributed nationwide. The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation,
| Recall number | Z-2933-2018 |
|---|---|
| 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 | 2018-07-12 |
| Classified | 2018-08-25 |
| Reported by FDA | 2018-09-05 |
| Terminated | 2020-07-02 |
| Distributed | Nationwide (US) |
| Reason classes | packaging, device malfunction |
Product
Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
Reason for recall
The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
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-2933-2018. 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.