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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm August 25, 2003
Date Posted October 15, 2003
Recall Status1 Terminated 3 on December 15, 2003
Recall Number Z-1280-03
Recall Event ID 27058
510(K)Number k952259  
Product Classification Unit, Phacofragmentation - Product Code HQC
Product Phaco Needles, catalog #DP8115, with 15 degree needle taper, labeld in part***Non-sterile, Manufactured for Bausch and Lomb, Inc. Rochester, NY 14609***, packaged 6 needles/box.
Code Information Julian date coded ''2003163''
Recalling Firm/
Bausch & Lomb Incorporated
1501 Graves Mill Road
Lynchburg VA 24502
For Additional Information Contact Jennifer B. Murray
Manufacturer Reason
for Recall
The firm's DP8200 Microflow Needle Packs were labeled with the firm's DP8115 Phaco Needle Packs and visa versa.
FDA Determined
Cause 2
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.
Quantity in Commerce 44 boxes
Distribution Product was sold to 6 direct accounts in FL, IA, WI, MA and IL. Product was additionally sold to 4 international distributors.
Total Product Life Cycle TPLC Device Report

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.
510(K) Database 510(K)s with Product Code = HQC and Original Applicant = STORZ INSTRUMENT CO.