OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)
FDA device recall Z-1520-06 · posted 2006-09-23 · Terminated
Recall details
- Recalling firm
- Oasis Medical Inc
- Reason for recall
- Labeled with an incorrect diameter
- Action taken
- 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.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- LZU
- Quantity affected
- 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.
- Date initiated
- 2006-07-06
- Date posted
- 2006-09-23
- Date terminated
- 2011-09-01
- Location
- Glendora, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SOFT PLUG ABSORBABLE PLUG-SA (K013613) | Oasis Medical, Inc. | 2002-06-27 |