Premier Edge MVR 19g Microsurgical Knife, Item PE-3519

FDA device recall Z-0995-2007 · posted 2007-07-04 · Terminated

Recall details

Recalling firm

Oasis Medical Inc

Reason for recall

This voluntary recall has been initiated due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled.

Action taken

Notification of the recall sent to distributors and users. The 06/08/07 letter requests customers to notify down to the user level. Included in the Recall Notification Letter are instructions: "In addition, if you may have further distributed this product, please identify your customers and notify them at once ofthis product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent any inconvenience."

Root cause

Device Design

Status

Terminated

Product code

HNN

Distribution

Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania.

Date initiated

2007-06-08

Date posted

2007-07-04

Date terminated

2009-09-25

Location

Glendora, CA