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U.S. Department of Health and Human Services

Class 2 Device Recall PremierEdge MICROSURGICAL KNIFE 15 DEGREES STAB KNIFE

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 Class 2 Recall
PremierEdge MICROSURGICAL KNIFE 15 DEGREES STAB KNIFE
see related information
Date Posted January 12, 2008
Recall Status1 Terminated on September 25, 2009
Recall Number Z-0490-2008
Recall Event ID 45870
Product Classification Knife, Ophthalmic - Product Code HNN
Product PremierEdge, MICROSURGICAL KNIFE,15 DEGREES STAB KNIFE, REF/Item Code: PE 3015, OASIS Glendora, CA 91741
Code Information Lot No.: DK1106M, DK1106T, and DK0207R
Recalling Firm/
Manufacturer
Oasis Medical Inc
514 S Vermont Ave Bldg 510-528
Glendora, California 91741-6205
For Additional Information Contact Robyn Scopis
800-528-9786
Manufacturer Reason
for Recall
Sterility (package integrity) compromised: the device is puncturing the packing during handling. Once the packaging is damaged, the product is no longer sterile as labeled. THIS IS AN EXPANSION OF A PREVIOUS RECALL
FDA Determined
Cause 2
DESIGN: Packaging Design/Selection
Action A recall notification, Urgent Medical Device Recall Expansion Letter, dated 7.18.2007, was sent to customers advising the letter is to inform them of a voluntary product recall expansion involving the OASIS Medical Premier Edge Knives. A product label for ease in identifying the product is included. The letter further advises this voluntary recall has been expanded due to the product puncturing the packing during rough handling. Once the packaging is damaged, the product is no longer sterile as labeled. The letter instructs customers to immediately examine their inventory and quarantine product subject to recall. Once the product has been identified, product is to be returned by FedEx to OASIS Medical. The letter further instructs that if the customer has further distributed this product, to identify their customers and notify them at once of this product recall. This recall should be carried out to the user level.
Quantity in Commerce 28,319 individual knives (Z-0485-0516-2008)
Distribution Worldwide: USA, Kuwait, Lebanon, Lithuania, Mexico, Netherlands, Norway, South Africa, Saudi Arabia, Slovakia, Spain, Sweden, Switzwerland, Turkey, United Kingdom, Ecuador, Finland, France, Germany, Greece, Italy, Denmark, Columbia, Chile, Brazil, Belgium, and Australia
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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