Device recall

Z-0267-2010: Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use…

FDA device recall · Class II · Sharn, Inc.

Key facts

Recall number (Z-number) Z-0267-2010
Recall event 53497
Product Nasal Mucosal Atomizer Device without syringe, LATEX FREE For Single Patient Use Only Packaged Clean -Non-Sterile- MADE IN CANADA. REF: LTAD-N3-25, Lot 121608, packed 25 per package. REF: LTAD-N3-100, Lot 121608, packed 100 per package. Manufactured By: Southmedic 50 alliance Blvd, Barrie, Ontario…
Product code CCT
Recalling firm Sharn, Inc.
Recall class Class II
Status Terminated
Termination date Jul 13, 2012
510(k) numbers K070596
FEI number 3020651884

At a glance

  • 1–9 Linked 510(k)s
  • 1–9 Products in the same recall event
  • 1–9 Recalled products with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About FDA device recalls (products)

Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.

Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database

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