| Class 2 Device Recall Bausch & Lomb Millenium Phacoemulsification Needle, Thin Tip 30 Degree | |
Date Initiated by Firm | March 26, 2008 |
Date Posted | September 16, 2008 |
Recall Status1 |
Terminated 3 on January 21, 2010 |
Recall Number | Z-2048-2008 |
Recall Event ID |
47422 |
510(K)Number | K041998 |
Product Classification |
Reprocessed phacoemulsification needle - Product Code NKX
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Product | Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 30 Degree, REF DP8430, 6 needles per pouch, nonsterile. |
Code Information |
Lot numbers 3169293, 3169294, 3170628, 3171200, 3171343, 3171344, 3171560, 3171561, 3171817, 3172015, 3172113, 3172114, 3172322, 3172527, 3172529 |
Recalling Firm/ Manufacturer |
Bausch & Lomb Inc 1400 North Goodman Street Rochester NY 14609-3547
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For Additional Information Contact | Mike Judy 949-389-3601 |
Manufacturer Reason for Recall | The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable |
FDA Determined Cause 2 | Labeling Change Control |
Action | The recalling firm issued letters dated 3/26/08 through a contracted recall notification company who issued the letters via UPS return receipt. A confirmation form was enclosed which was to be completed and returned.
If you have questions, contact Customer Service at 1-800-338-2020. |
Quantity in Commerce | Total of all sizes - 4,055/6-needle packages |
Distribution | Distribution was made nationwide direct to medical facilities, which included some government accounts. Foreign distribution was made to Australia, Brazil, Bulgaria, Canada, China, Colombia, Cyprus, England, France, Germany, India, Iran, Ireland, Israel, Italy, Jordan, Korea, Lebanon.,The Netherlands, Poland, Portugal, Russia, Saudi Arabia, South Africa, Spain, Thailand, Turkey, and United Arab Emerites. |
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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510(K) Database | 510(K)s with Product Code = NKX
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