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U.S. Department of Health and Human Services

Class 2 Device Recall Pediatric LaryngoTracheal Atomizer Device without syringe

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 Class 2 Device Recall Pediatric LaryngoTracheal Atomizer Device without syringesee related information
Date Initiated by FirmMarch 05, 2009
Date PostedNovember 16, 2009
Recall Status1 Terminated 3 on July 13, 2012
Recall NumberZ-0265-2010
Recall Event ID 53497
510(K)NumberK070596 
Product Classification Laryngo-Tracheal Topical Anesthesia Applicator - Product Code CCT
ProductPediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA. REF: LTAD-PL7-25, Lot 121508, packed 25 per package. REF: LTAD-PL7-100, Lot 121508, packed 100 per package. 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 121508.
Recalling Firm/
Manufacturer		 Sharn, Inc.
4517 George Rd Ste 200
Tampa FL 33634
For Additional Information Contact
813-889-9614
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.
FDA Determined
Cause 2		Device Design
ActionRecalling 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 Commerce300
DistributionNationwide Distribution
Total Product Life CycleTPLC Device Report
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.
510(K) Database510(K)s with Product Code = CCT
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