Drainer — Class II medical device recall Z-2249-2018
Terminated recall by Vascular Solutions, Inc., reported 2018-06-27, distributed nationwide. The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for
| Recall number | Z-2249-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Vascular Solutions, Inc., Maple Grove, MN, United States |
| Recall initiated | 2018-05-04 |
| Classified | 2018-06-18 |
| Reported by FDA | 2018-06-27 |
| Terminated | 2020-10-05 |
| Distributed | Nationwide (US) |
| Quantity | 276 units |
| Reason classes | microbial contamination, sterility |
| Lot numbers | 18026062, 18026063, 18037128, 18050076, 18057123 |
| Model numbers | 15CM, 8810, 8811, 8812, 9CM |
Product
Drainer(R) Centesis Catheters: (a) REF 8810, 5F x 9cm (b) REF 8811, 6F x 9cm (c) REF 8812, 5F x 15cm Product The Drainer centesis catheter is intended for use in percutaneous fluid aspirations and small volume drainage procedures.
Reason for recall
The supplier of Drainer(R) centesis catheters notified Vascular Solutions, Inc. that there is a potential for certain production lots to contain unsafe levels of bacterial endotoxins.
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-2249-2018. 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.