Device recall

Z-1058-2007: Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant…

FDA device recall · Class II · Gebauer Company

Key facts

Recall number (Z-number) Z-1058-2007
Recall event 37778
Product Gebauer''s Spray and Stretch Fine- Stream Topical Anesthetic Skin Refrigerant -is intended for topical application to skin for use in controlling pain associated with injections and the temporary relief of minor sporsts injuries. Rx only- 3.5 fl. oz. (103.5ml) can-Product Number 0386-0004-04
Product code MLY
Recalling firm Gebauer Company
Recall class Class II
Status Terminated
Termination date Nov 30, 2009
510(k) numbers K031036
FEI number 1519179

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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