| Class 2 Device Recall Premier Edge MVR 20g Microsurgical Knife, Angled | |
Date Initiated by Firm | June 08, 2007 |
Date Posted | July 04, 2007 |
Recall Status1 |
Terminated 3 on September 25, 2009 |
Recall Number | Z-0997-2007 |
Recall Event ID |
38130 |
Product Classification |
Microsurgical Knife - Product Code HNN
|
Product | Premier Edge MVR 20g Microsurgical Knife, Angled, Item PE-3520-A |
Code Information |
Lot #'s DK0107Y, DK0307D, DK0307Q, DK1206M |
Recalling Firm/ Manufacturer |
Oasis Medical Inc 510-528 South Vermont Ave Glendora CA 91741
|
For Additional Information Contact | Robyn Scopis 626-852-5156 |
Manufacturer 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. |
FDA Determined Cause 2 | Device Design |
Action | 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." |
Distribution | Worldwide, including USA, Switzerland, Germany, England, UK, Turkey, Czech Republic, and Lithuania. |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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