Lma IPN046397

• • Terminated Z-3212-2017 FDA Class II ·initiated 5 Jul 2017 ·via K153470, on the same 510(k)

  Teleflex Medical is recalling the affected product because there may be missing or incomplete information on the package label.

• 2 recalls, same reason

  • Terminated Z-0384-2017 FDA Class II ·initiated 27 Oct 2016 ·via K153470, on the same 510(k)
  • Terminated Z-0383-2017 FDA Class II ·initiated 27 Oct 2016 ·via K153470, on the same 510(k)

  Product Defect; These products may produce a straight stream instead of a fully atomized plume of medication.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Trade Name

Lma

Generic Name

Basic endotracheal tube, single-use

Model / Ref / Catalog

IPN046397, MAD710

Primary DI / UDI-DI

05060112313219

510(k) Number

K153470 ↗

FDA Product Code

BTR

GMDN Term

Basic endotracheal tube, single-use

Device Class

Class II

Regulation Number

868.5730

Commercial Distribution

In Commercial Distribution

Category: Basic endotracheal tube, single-use