FDA Device recall Z-1339-2015
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by…
- FDA Device
- Class II
- terminated
- Published 2015-04-08
On 2015-04-08 the FDA classified a Class II recall of FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by… by Microtek Medical, citing this recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1339-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-10 |
| Published | 2015-04-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Microtek Medical |
| Distribution | US |
Product
FREEDOMAIRE(R) HELMET WITH MOTOR MODULE, REF 11113STK, QTY 1/CS, NON STERILE, NO LATEX The Surgical Helmet System is intended to be worn by surgical personnel to provide barrier between the operating environment and the surgical personnel in order to protect against contamination, body fluids and microorganisms.
Reason
This recall is being conducted because a cohesive band used to package the devices contains latex and the product is not labeled as required by 21 CFR 801.437; it does not contain Caution: The Packaging of This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Identifiers
| code_info | Lot Numbers: C9257, C9324, C10025, C10043, C10067, C10165, C10230, C10237, C11321, C11325, C12251, C13063, C13325 |
|---|
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-1339-2015%22
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