IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction… — Class II medical device recall Z-2422-2015
Terminated recall by International Biophysics Corp., reported 2015-08-26, distributed nationwide. It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
| Recall number | Z-2422-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | International Biophysics Corp., Austin, TX, United States |
| Recall initiated | 2015-08-07 |
| Classified | 2015-08-19 |
| Reported by FDA | 2015-08-26 |
| Terminated | 2016-03-01 |
| Distributed | Nationwide (US) |
| Countries outside the US | CL, DE, NO, PK, TR, ZA |
| Quantity | 100 units |
| Reason classes | potency, sterility, packaging |
| Model numbers | 1990S |
Product
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart procedures, autologous blood recovery and blood suction. It is a disposable, single use component.
Reason for recall
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
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-2422-2015. 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.