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U.S. Department of Health and Human Services

Class 2 Device Recall Surgical Headlight

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 Class 2 Recall
Surgical Headlight
see related information
Date Posted January 20, 2012
Recall Status1 Terminated on August 28, 2012
Recall Number Z-0831-2012
Recall Event ID 58983
Premarket Notification
510(K) Number
K061690 
Product Classification Light, Surgical, Fiberoptic - Product Code FST
Product Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, and GMF-H106. The Surgical Headlight is a passive luminaire. It is illuminated by a source of light by way of the fiber optics and provides supplemental lighting for medical and surgical procedures.
Code Information Model Numbers: GMF-H001, GMF-H100, GMF-H101, GMF-H102, GMF-H103, GMF-H104, GMF-H105, GMF-H106.
Recalling Firm/
Manufacturer
Gulf Medical Fiberoptics, Inc.
448 Commerce Blvd.
Oldsmar, Florida 34677
Consumer Instructions No consumer action necessary
For Additional Information Contact Jacqueline Armand
813-855-6618
Manufacturer Reason
for Recall
Gulf Medical Fiberoptics, Inc. recalled their Surgical Headlight because the cleaning instructions for the exterior surfaces of the headlight , headgear and fiber cable with 70% isopropyl alcohol had not been validated.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action On May 16, 2011, Gulf Medical Fiberoptics, Inc. issued to all customers an updated letter to their May 13, 2011 "Field Correction of Instructions For Use" informing them to discontinue the use of 70% isopropyl to clean the surfaces of the device. Enclosed with the letter was an updated Surgical Headlight User Guide with instructions to discard/shred/recycle the prior guide. The firm asked customers to return a form acknowledging the receipt and action from the letter. Customers with questions should contact Customer Service department manager Jacqueline Armand at 813-855-6618 ext. 427.
Quantity in Commerce 381 units
Distribution Worldwide Distribution - USA, including the states of FL, WI, WA, AL, CA, MO, MI, OH, VA, CO, TX, TN, NC and the countries of Turkey, Brazil, Belgium, South Korea, Panama, Mexico, Ireland, Taiwan (ROC), Italy, Argentina, India, Spain, Germany, and Venezuela.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FST and Original Applicant = GULF MEDICAL FIBEROPTICS
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