FDA-Device2019-11-27Class II
Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
Cook Inc.
Hazard
Lidstock perforation line may be over the sterile area of the tray, when it should be on the lip of the tray, potentially compromising the sterility of the device.
Sold states
US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.
Affected count
41 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 - Product Usage: The modified Wayne Pneumothorax Set is used for the relief of simple, spontaneous, iatrogenic, and tension pneumothorax.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2020Don't want to check this manually?
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