FDA Medical Device Recalls (openFDA)
Oasis Medical Inc: OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)
- Recall number
- Z-1520-06
- Recalling firm
- Oasis Medical Inc
- Product
- OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)
- Status
- Terminated
- Initiated
- 2006-07-06
- Posted
- 2006-09-23
- Terminated
- 2011-09-01
- Reason
- Labeled with an incorrect diameter
- Root cause
- Package design/selection
- Action
- OASIS Medical informed all customers via FAX and Certified Mailt that received the product that the firm was voluntarily recalling one lot of the SOFT PLUG Extended Duration Plugs (REF 6403) and to cease use immediately. Customers are advised to check their inventory and return any remaining and return all unused product to OASIS Medical SOFT PLUG Extended Duration Plugs (REF 6403) from Lot LA1105E by FedEx. Customers are also advised that if they have used the product, to inform OASIS Medical of the number of samples of this lot used for an accurate account of the product distributed, used and returned.
- Quantity
- 1,212 SOFT PLUG¿ Extended Duration Plug pouches of Lot LA1105E. Each pouch contains 2 plugs.
- Distribution
- Worldwide distribution ----USA and countries of Chile, and United Kingdom.
- Lot, serial or model codes
- Lot LA1105E
- 510(k) numbers
- ["K013613"]
- PMA numbers
- not on file
- Product code
- LZU
- Firm FEI
- 2083373
- Firm city
- Glendora
- 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