Z-2045-2008

Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30 Degree, REF DP8130, 6 needles per...

Name: Z-2045-2008 Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30 Degree, REF DP8130, 6 needles per...
Creator: Bausch & Lomb Inc
Published: 2008-03-26
License: https://open.fda.gov/license/

Bausch & Lomb Incorporated / initiated 2008-03-26 / Terminated / root cause: labeling and UDI

FDA source

Bausch & Lomb Inc began a recall of Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30 Degree, REF DP8130, 6 needles per pouch, nonsterile on 2008-03-26. The reason FDA records is "The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2045-2008
Status: Terminated
Initiated: 2008-03-26
Posted: 2008-09-16
Terminated: 2010-01-21
Recalling firm: Bausch & Lomb Incorporated
Product: Bausch & Lomb Millenium Phacoemulsification Needles, Needle Tapered Hub 30 Degree, REF DP8130, 6 needles per pouch, nonsterile.
Product code: NKX Needle, Phacoemulsification, Reprocessed
Reason for recall: The directions for use are printed with the incorrect symbols to indicate the product is packaged as sterile and nonreusable
Root cause tag: labeling and UDI
FDA root cause: 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.
Product codes and lots: Lot numbers 3168943, 3169532, 3169835, 3170331, 3170923, 3171342, 3171562, 3171566, 3172013, 3172110, 3172318, 3172319

Product code NKX

K041998Class IIPhaco Chop NeedlesBausch & Lomb, Inc. / cleared 2004-08-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)