FDA Medical Device Recalls (openFDA)
Sharn, Inc.: 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: 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.
- Recall number
- Z-0265-2010
- 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: 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.
- Status
- Terminated
- Initiated
- 2009-03-05
- Posted
- 2009-11-16
- Terminated
- 2012-07-13
- Reason
- 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
- 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
- 300
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- Lot 121508.
- 510(k) numbers
- ["K070596"]
- PMA numbers
- not on file
- Product code
- CCT
- Firm FEI
- 3020651884
- Firm city
- Tampa
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28