FDA Medical Device Recalls (openFDA)
Encision, Inc.: Encision ES4107 Disposable AEM Cord, Sterile.
- Recall number
- Z-1132-04
- Recalling firm
- Encision, Inc.
- Product
- Encision ES4107 Disposable AEM Cord, Sterile.
- Status
- Terminated
- Initiated
- 2004-07-09
- Posted
- 2004-07-22
- Terminated
- 2004-12-14
- Reason
- Firm found pinholes in packaging which would compromise sterility.
- Root cause
- Other
- Action
- Affected customers were notified by fax or mail on 7/15/2004.
- Quantity
- 73 units
- Distribution
- AL, CA, GA, KS, KY, MI, MN, MS, NC, NH, NY, OH, OK, SD, TN, WA, WY. Foreign Distribution to Australia and Japan. Includes military facilities in GA, MS, and Japan.
- Lot, serial or model codes
- REF ES4107, Lot Numbers 900032, 0094, HB, HBA, HC, HD, HE, HF, HFA, HG, HI.
- 510(k) numbers
- ["K913625"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 1000117361
- Firm city
- Boulder
- Firm state
- CO
- 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