Surgical Headlight labeled in part *Gulf Medical Fiberoptics*OLDSMAR, FLORIDA U.S.A.* Model Numbers: GMF-H001, GMF-H100,
FDA device recall Z-0831-2012 · posted 2012-01-20 · Terminated
Recall details
- Recalling firm
- Gulf Medical Fiberoptics, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- FST
- Quantity affected
- 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
- Date initiated
- 2011-05-13
- Date posted
- 2012-01-20
- Date terminated
- 2012-08-28
- Location
- Oldsmar, FL
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SURGICAL HEADLIGHT (K061690) | Gulf Medical Fiberoptics | 2006-09-15 |