Device recall

Z-0347-2011: SP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button…

FDA device recall · Class I · Micromedics, Inc.

Key facts

Recall number (Z-number) Z-0347-2011
Recall event 56874
Product SP78100, SP78105 Nasal Products, Catalog Number SP-78100, Nasal Septal Button Standard (3cm), Rx Only, Sterilized by Ethylene Oxide, Micromedics Inc., St Paul, MN 55121-1385. Nasal Products, Catalog Number SP-78105, Nasal Septal Button Oversize (5cm), Rx Only, Sterilized by Ethylene Oxide…
Product code LFB
Recalling firm Micromedics, Inc.
Recall class Class I
Status Terminated
Termination date Jun 21, 2011
510(k) numbers K982667
FEI number 2183425

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

Browse all FDA device recalls (products)