FDA Medical Device Recalls (openFDA)
Chalgren Enterprises Inc: Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.
- Recall number
- Z-2446-2010
- Recalling firm
- Chalgren Enterprises Inc
- Product
- Disposable Detachable Monopolar Needle Electrode for electromyograph model number 110-725, for Physician use, manufactured by Chalgren Enterprises Inc., Gilroy, CA.
- Status
- Terminated
- Initiated
- 2007-04-12
- Posted
- 2010-09-21
- Terminated
- 2011-03-24
- Reason
- Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility.
- Root cause
- Packaging
- Action
- Chalgren Enterprises, Inc. removed all of the affected inventory from inventory and had all affected inventory retrieved from distribution.
- Quantity
- not on file
- Distribution
- Nationwide Distribution: USA states of CA, IL, NJ, OH and TX.
- Lot, serial or model codes
- Lot number P059
- 510(k) numbers
- ["K912283"]
- PMA numbers
- not on file
- Product code
- IKT
- Firm FEI
- 2939713
- Firm city
- Gilroy
- Firm state
- CA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28