FDA Medical Device Recalls (openFDA)
Medical Action Industries Inc: Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
- Recall number
- Z-1954-2014
- Recalling firm
- Medical Action Industries Inc
- Product
- Max Barrier Kit, Sterile Single Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
- Status
- Terminated
- Initiated
- 2014-06-12
- Posted
- 2014-07-01
- Terminated
- 2015-02-03
- Reason
- Some of the sterile kits may have incomplete seals which might compromise the sterility of the kits.
- Root cause
- Nonconforming Material/Component
- Action
- Consignees were notified via E-Mails, Certified Letters and Telephone on 06/12/2014.
- Quantity
- 474 cs (9,480 ea) total for all kits involved
- Distribution
- Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
- Lot, serial or model codes
- Model number: 70828, Lot number: 187176, Exp. Date: 1/1/2016.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OVN
- Firm FEI
- 1030451
- Firm city
- Arden
- Firm state
- NC
- 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