FDA Medical Device Recalls (openFDA)
Ferndale Laboratories, Inc.: Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.
- Recall number
- Z-0413-2011
- Recalling firm
- Ferndale Laboratories, Inc.
- Product
- Detachol adhesive remover, 4 fl oz (118 mL), Marketed by Eloquest Healthcare, Inc., a Ferndale Pharma Group company, Manufactured by Ferndale Laboratories, Inc., Ferndale, MI 48220 U.S.A.
- Status
- Terminated
- Initiated
- 2010-07-07
- Posted
- 2010-10-26
- Terminated
- 2011-03-02
- Reason
- There is a defect on the neck surface of the bottles, causing bottles to leak. Bottle defect may potentially cause contamination of solvent stored in bottles.
- Root cause
- Other
- Action
- Ferndale Pharma Group issued an Urgent Medical Device Recall letter dated July 7, 2010 to customers identifying the affected product. Customers were instructed to identify and quarantine all affected product and return it to Ferndale Laboratories for a credit. Customers are requested to complete and return an enclosed response form. Customers can contact Ferndale at 800-621-6003.
- Quantity
- 55,000 bottles
- Distribution
- Nationwide Distribution: Throughout the US.
- Lot, serial or model codes
- LOTS: 09216B, 09218A, 09219A, 09231A, 09232A, 10003A, and 10004A.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KOX
- Firm FEI
- 1811212
- Firm city
- Ferndale
- Firm state
- MI
- 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