Z-0265-2010

Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged...

Name: Z-0265-2010 Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged...
Creator: Sharn, Inc.
Published: 2009-03-05
License: https://open.fda.gov/license/

Sharn, Inc. / initiated 2009-03-05 / Terminated / root cause: design

FDA source

Sharn, Inc. began a recall of Pediatric Laryngo-Tracheal Atomizer Device without syringe, LATEX FREE For Single patient Use Only Packaged Clean -Non-Sterile-, MADE IN CANADA. REF... on 2009-03-05. The reason FDA records is "Sharn Anesthesia Inc., Tampa, FL received reports of leaking containers following use of their Sharn Anesthesia Microblast nasal and pediatric laryngeal atomizer device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0265-2010
Status: Terminated
Initiated: 2009-03-05
Posted: 2009-11-16
Terminated: 2012-07-13
Recalling firm: Sharn, Inc.
Product: Pediatric 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: [email protected] 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.
Product code: CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
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.
Root cause tag: design
FDA root cause: 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: 300
Distribution: Nationwide Distribution
Product codes and lots: Lot 121508.

Product code CCT

K070596Class IITopical ApplicatorSharn, Inc. / cleared 2007-06-21

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)