Device product
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.
Z-0506-2020
Product summary
- Firm
- Cook Inc.
- Event
- Event 83921
- Status
- Terminated
- Classification
- Class II
- Quantity
- 41 units
- Official record key
device-enforcement:Z-0506-2020
Official wording
Reason: 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.
Code information: Lot 9850522
Distribution pattern: US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.
Derived failure modes
-
Unknown
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.