Class 2 Device Recall Keeler All Pupil II Indirect Ophthalmoscope

• Date Initiated by Firm: January 08, 2008
• Date Posted: May 22, 2008
• Recall Status: Terminated on August 12, 2008
• Recall Number: Z-1132-2008
• Recall Event ID: 46741
• 510(K)Number: K854244
• Product Classification: Ophthalmoscope - Product Code HLI
• Product: Keeler All Pupil II Indirect Ophthalmoscope, Keeler Instruments, Inc., Broomall, PA 19008
• Code Information: Serial numbers: 86249, 85806, 85598, 85601, 86390, 67321, 85600, 85697, 86372, 86394, 85599, 85602, 66378, 85814, 86392, 85605, 66886, 66708, 86255, 85565, 85556, 85558, 85562, 86370, and 66882.
• Recalling Firm/ Manufacturer: Keeler Instruments Inc; 456 Parkway; Broomall PA 19008
• For Additional Information Contact: Eugene R. VanArsdale; 610-353-4350
• Manufacturer Reason for Recall: Good Manufacturing Practices (GMP) deficiencies may compromise the safety and effectiveness of the device. Firm is on import alert 89-04 and released product.
• FDA Determined Cause: Process design
• Action: Keeler Instruments issued an email dated 1/8/08 to the distributor requesting that they return the product.
• Quantity in Commerce: 25 units
• Distribution: The products were shipped to a distributor in NJ.
• 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 = HLI