Z-1520-06

OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)

Name: Z-1520-06 OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)
Creator: Oasis Medical Inc
Published: 2006-07-06
License: https://open.fda.gov/license/

Oasis Medical, Inc. / initiated 2006-07-06 / Terminated / root cause: packaging

FDA source

Oasis Medical Inc began a recall of OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E) on 2006-07-06. The reason FDA records is "Labeled with an incorrect diameter". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1520-06
Status: Terminated
Initiated: 2006-07-06
Posted: 2006-09-23
Terminated: 2011-09-01
Recalling firm: Oasis Medical, Inc.
Product: OASIS Medical SOFT PLUG Extended Duration Plug, Reference 6403 (Lot LA1105E)
Product code: LZU Plug, Punctum
Reason for recall: Labeled with an incorrect diameter
Root cause tag: packaging
FDA 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 in commerce: 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.
Product codes and lots: Lot LA1105E

Product code LZU

K013613UnclassifiedSoft Plug Absorbable Plug-SaOasis Medical, Inc. / cleared 2002-06-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)