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Class 2 Device Recall Nasal Mucosal Atomizer Device without syringe |
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Date Initiated by Firm |
March 05, 2009 |
Date Posted |
November 16, 2009 |
Recall Status1 |
Terminated 3 on July 13, 2012 |
Recall Number |
Z-0267-2010 |
Recall Event ID |
53497 |
510(K)Number |
K070596
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Product Classification |
Laryngo-Tracheal Topical Anesthesia Applicator - Product Code CCT
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Product |
Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA.
REF: LTAD-N3-25, Lot 121608, packed 25 per package. REF: LTAD-N3-100, Lot 121608, packed 100 per package.
Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario, Canada L4M 5K3. Distributed By: Sharn Inc. Anesthesia 1-800-325-3671 813-886-2701 email: mailbox@sharn.com
The device is used to deliver a fine mist numbing agent to the nose or throat for intubating a patient immediately prior to undergoing anesthesia. |
Code Information |
Lot 121608. |
Recalling Firm/ Manufacturer |
Sharn, Inc. 4517 George Rd Ste 200 Tampa FL 33634
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For Additional Information Contact |
813-889-9614
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Manufacturer Reason for Recall |
Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device.
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FDA Determined Cause 2 |
Device Design |
Action |
Recalling firm is contacting all direct accounts (distributors & user facilities) by telephone and letter. They request completion and return of the of the Return Goods Form and of any affected product by UPS using the firm's account number. |
Quantity in Commerce |
2375 |
Distribution |
Nationwide Distribution |
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 = CCT and Original Applicant = SHARN, INC.
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