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U.S. Department of Health and Human Services

Class 2 Device Recall Keeler All Pupil II Indirect Ophthalmoscope

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  Class 2 Device Recall Keeler All Pupil II Indirect Ophthalmoscope see related information
Date Initiated by Firm January 08, 2008
Date Posted May 22, 2008
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = KEELER INSTRUMENTS, INC.
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