FDA Device recall Z-2422-2015
IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart pro…
- FDA Device
- Class II
- terminated
- Published 2015-08-26
On 2015-08-26 the FDA classified a Class II recall of IBC Suction Wand Catalog Number 1990S Product Usage: The IBC Suction Wand is a component of Blood Recovery System for use in open heart pro… by International Biophysics, citing it was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2422-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-07 |
| Published | 2015-08-26 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | International Biophysics |
| Distribution | US |
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
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Identifiers
| code_info | 033115-3445 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2422-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.