Microflow Needles, catalog #DP8200, with 0 degree tapering, labeled in part ***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
FDA Recall Z-1279-03 · Posted 2003-10-15
Advertisement
Recalling FirmBausch & Lomb Incorporated
Recall StatusTerminated
Product CodeHQC
Date Initiated2003-08-25
Date Terminated2003-12-15
Product Quantity22 boxes
Reason for Recall
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
Firm Action
Firm notified customers by phone and letter 8/25/2003 and advised of needle mix-up. Customers were requested to quarantine affected product and return product with response form.
Root Cause
Other
Distribution Pattern
Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.
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.
Advertisement