Bausch & Lomb Millennium Phacoemulsification Needles, Needle Tapered Hub 15 Degree, REF DP8115, 6 needles per pouch, nonsterile.
This recall has been terminated (originally issued September 16, 2008).
- Company
- Bausch & Lomb Inc
- Recall Initiated
- March 26, 2008
- Posted
- September 16, 2008
- Terminated
- January 21, 2010
- Recall Number
- Z-2044-2008
- Quantity
- Total of all sizes - 4,055/6-needle packages
- Firm Location
- Rochester, NY
- Official Source
- View on FDA website ↗
Reason for Recall
The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
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.
Lot / Code Info
Lot number 3168901
Root Cause
Labeling Change Control
Action Taken
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.