Recall Z-0265-2010 ยท CCT Applicator (Laryngo-Tracheal), Topical Anesthesia
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: mai
| Date | Nov 16, 2009 (initiated Mar 5, 2009) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070596 | TOPICAL APPLICATOR Sharn, Inc., Jun 21, 2007 |