FDA Medical Device Recalls (openFDA)
Epimed International: COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
- Recall number
- Z-0088-2018
- Recalling firm
- Epimed International
- Product
- COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
- Status
- Terminated
- Initiated
- 2017-07-24
- Posted
- not on file
- Terminated
- 2023-07-06
- Reason
- Potential for partially incomplete seal of product, impacting sterility.
- Root cause
- Employee error
- Action
- Consignees were contacted 07/24/2017 via email and phone, notifying them of the recall. Consignees were asked to contact the recalling firm to report the number of affected product on hand. A second, updated recall notification was sent on 08/04/2017. Instructions included to examine inventory and quarantine any affected product, contact Epimed to arrange return/credit of the affected product, and complete and return the response form.
- Quantity
- 300 units
- Distribution
- Domestic: AR, CA, IA, IN, KY, LA, MI, NY, OH, OR, TN, TX, & WA. Foreign: Canada, Czech Republic, Germany ,& Turkey.
- Lot, serial or model codes
- Lot No. 12608201; Ref No. 117-2260.
- 510(k) numbers
- ["K041843"]
- PMA numbers
- not on file
- Product code
- OGE
- Firm FEI
- 1643059
- Firm city
- Farmers Branch
- Firm state
- TX
- 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