FDA Device recall Z-0650-2013
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Ter…
- FDA Device
- Class II
- terminated
- Published 2013-01-16
On 2013-01-16 the FDA classified a Class II recall of Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Ter… by California Medical Laboratories, citing california Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come l….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0650-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-11-02 |
| Published | 2013-01-16 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | California Medical Laboratories |
| Distribution | AZ, CA, CO, FL, LA, MS |
Product
Rigid Tip Suction Wand Non sterile bulk devices (S112468N, S120196N, and S120197N) were sold to Terumo UK to be included in a kit under Terumo as manufacturer's name. The Suction Wands are indicated for use to remove excess fluid from the surgical field.
Reason
California Medical Laboratories, Inc. has identified an issue with the Rigid Tip Suction Wand. Due to insufficient adhesive application, the distal tip has the potential to come loose from the wand and fall into the patient's chest cavity.
Identifiers
| code_info | Catalog No: SU-12202NS Lot No: S112468N, S120196N, S120197N |
|---|
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-0650-2013%22
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