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Terminated

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

FDA Recall Z-1520-06 · Posted 2006-09-23

Recalling FirmOasis Medical Inc
Recall StatusTerminated
Product CodeLZU
Date Initiated2006-07-06
Date Terminated2011-09-01
Product Quantity1,212 SOFT PLUG¿ Extended Duration Plug pouches of Lot LA1105E. Each pouch contains 2 plugs.

Reason for Recall

Labeled with an incorrect diameter

Firm 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.

Root Cause

Package design/selection

Distribution Pattern

Worldwide distribution ----USA and countries of Chile, and United Kingdom.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013613SOFT PLUG ABSORBABLE PLUG-SAOasis Medical, Inc. · 2002-06-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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