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Class 2 Device Recall Green RuschLite Disposable Metal Larynogoscope Blade. |
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| Date Initiated by Firm |
October 15, 2013 |
| Date Posted |
November 20, 2013 |
| Recall Status1 |
Terminated 3 on November 04, 2015 |
| Recall Number |
Z-0366-2014 |
| Recall Event ID |
66640 |
| Product Classification |
Rigid Laryngoscope - Product Code CCW
|
| Product |
Green Rusch - Lite Disposable Metal Laryngoscope Ridge Blade to visualize upper airway and aid in placement of tracheal tube. |
| Code Information |
Product Code 004551004; Lot 1305342 |
Recalling Firm/
Manufacturer |
Teleflex Medical
4024 Stirrup Creek Dr
Durham NC 27703-9000
|
| For Additional Information Contact |
Michael Taggart
919-433-4816
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Manufacturer Reason
for Recall |
Labeling inconsistency
|
FDA Determined
Cause 2 |
Other |
| Action |
Recall letters were sent to customers and distributors on 10/15/2013 via courier. The letter indicated that the consignee was to immediately discontinue use and quarantine any products with the affected catalog numbers. The letter also included a Recall Acknowledgment Form which was to be faxed back to the firm. |
| Quantity in Commerce |
6,200 ea. |
| Distribution |
Nationwide distribution: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KY, LA, MD, MA, MI, MN, MO, NE, NJ, NM, NY, NC, OH, OK, OR, PA, SC, TN, TX, VA, WA, WV and WI. |
| 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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