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Medical Devices Sector
قطاع الأجهزة الطبية
NCMDR
National Center for Medical Devices Reporting
المركز الوطني لبلاغات الأجهزة والمنتجات الطبية
NCMDR Recall
Reference Number: mdprc 138 07 16 000
Date submitted: 7/21/2016
Manufacturer:DeRoyal Industries Inc.
Device Type:DeRoyal Isolation Bag
Description:Descriptor- lntraoperative Procedure Bag
Medical Device Identifier:The lot affected was manufactured on production work order 14097259
Reason of Field Safety Corrective Action:The issue reported and confirmed is that the product labeling for this lot states the product lot is STERILE, however there is also a statement on the product labeling which states "Non-sterile". The product is mislabeled, the error is that the product labeling states "Non-sterile". Upon investigation of this report, DeRoyal confirmed that this product, Isolation Bag 30-5510, is required to be sterilized with ethylene oxide gas during the operational processes at DeRoyal prior to release.
Remedy Action:(1) Use DeRoyal product in accordance with recommended healthcare protocol
(2) In case of visible damage to pouch or package, do not use. If product pouch packaging has no opening or tear, the product is sterile.
(3) The labeling statement "Non-sterile" could cause concern to the end user, however the product was sterilized and is guaranteed sterile unless open or damaged.
(4) Product labeling is incorrect and misleading, however product lot is sterile.
Athorized Representative/Importer/Distributor:Alhaya medical co.
Report Source:NCMDR
Source Ref. Number:D247E7AE422F0
SFDA Comments:SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments: Deroyal.pdf