Tray Surgical, ENT (various instrument trays) Used for stot age and transportation of reusable surgical instruments util

FDA device recall Z-1934-2013 · posted 2013-08-09 · Terminated

Recall details

Recalling firm

Medtronic Xomed, Inc.

Reason for recall

The firm will recall and replace the identified instrument trays in the field, with trays that have improved labeling, including lids that contain the statement indicating 'PREVACUUM ONLY"

Action taken

Medtronic sent a Customer Commincation Recall Letter to all affected customers with the following information: Subject: URGENT PRODUCT Recall Immediate Attention Required MEDTRONIC XOMED INSTRUMENT TRAYS - model numbers provided on Attachment One - all lots distributed prior to July 2013 Dear Purchasing Manager, Risk Manager and Central Supply Manager/Supervisor: This letter is to inform you that Medtronic Surgical Technologies (ENT Division) is initiating a voluntary recall to remove certain instrument trays from the field and replace them with trays that have modified labeling. Medtronic Xomed Instrument Trays are intended for the storage and transportation of reusable surgical instruments. These trays are not intended and not designed to maintain sterility. We are aware, however, that some users may also choose to use the trays for holding instruments during steam sterilization. If the user chooses to sterilize instruments within these instrument trays, they must validate the sterilization process. These users should be aware of the following issue: Issue Description: During the validation of a new instrument, testing revealed that use of a GRAVITY steam cycle with one of the listed instrument trays did not produce the Sterility Assurance Level (SAL) of 10-6 recommended by industry standard (ANSI/AAMI ST77:2006). A subsequent investigation of all Medtronic Xomed instrument trays identified additional trays as having certain locations within the tray that would not meet the recommended sterilization level of SAL10-6 during GRAVITY steam sterilization cycles. The trays identified through the testing are the subject trays involved in this field action. Instruments that are sterilized in the worst-case locations of the identified trays have a higher potential to be inadequately sterilized. An instrument that is inadequately sterilized can become the source of cross-contamination or cross-infection when used in multiple surgical procedures. At this time

Root cause

Device Design

Status

Terminated

Product code

MMO

Quantity affected

3,562 trays

Distribution

Worldwide Distribution - USA (nationwide) Nationwide, Hawaii, Puerto Rico and Guam. Internationally to: Canada, Austria, Belgium, Cyprus, France, Germany, Greece, India, Iran, Ireland, Israel, Italy,

Date initiated

2013-07-09

Date posted

2013-08-09

Date terminated

2014-09-25

Location

Jacksonville, FL