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.
FDA Recall Z-0265-2010 · Posted 2009-11-16
Advertisement
Recalling FirmSharn, Inc.
Recall StatusTerminated
Product CodeCCT
Date Initiated2009-03-05
Date Terminated2012-07-13
Product Quantity300
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.
Firm 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.
Root Cause
Device Design
Distribution Pattern
Nationwide Distribution
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement