Bausch & Lomb Millenium Phacoemulsification Needles, Needle Thin Tip 30 Degree, REF DP8430, 6 needles per pouch, nonsterile.
FDA Recall Z-2048-2008 · Posted 2008-09-16
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Recalling FirmBausch & Lomb Inc
Recall StatusTerminated
Product CodeNKX
Date Initiated2008-03-26
Date Terminated2010-01-21
Product QuantityTotal of all sizes - 4,055/6-needle packages
Reason for Recall
The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Firm 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.
Root Cause
Labeling Change Control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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