• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall CustomPak Surgical Packs

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall CustomPak Surgical Packssee related information
Date Initiated by FirmDecember 22, 2006
Date PostedMarch 01, 2007
Recall Status1 Terminated 3 on June 06, 2007
Recall NumberZ-0564-2007
Recall Event ID 37153
Product Classification Surgical Packs - Product Code HNN
ProductAlcon Custom-Pak, part #11148-02, containing BD Beaver Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
Code Information Lot #632178H, 634400H and 642229H.
Recalling Firm/
Manufacturer
Alcon Laboratories, Inc
9965 Buffalo Speedway
Houston TX 77054-1309
Manufacturer Reason
for Recall
Individually packaged surgical blades, labeled as sterile, found with incomplete seals; blades purchased for use in custom surgical packs.
FDA Determined
Cause 2
Other
ActionCustomers notified of recall via phone on 12/22/06, with follow-up fax and letter. A revised notification was made via phone and fax to each customer on 12/26/06. Customers instructed not to use blades and to return blades for a replacement. Recall to the user/hospital level.
Quantity in Commerce65 custom surgical packs.
DistributionCustom surgical packs sold to hospitals in AR, MN, NY, TX and WI.
Total Product Life CycleTPLC 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.
-
-