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Class 2 Device Recall Keeler All Pupil II Indirect Ophthalmoscope |
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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
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Product Classification |
Ophthalmoscope - Product Code HLI
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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
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For Additional Information Contact |
Eugene R. VanArsdale 610-353-4350
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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.
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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
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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.
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510(K) Database |
510(K)s with Product Code = HLI and Original Applicant = KEELER INSTRUMENTS, INC.
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