Z-0506-2020 Class II Terminated
FDA device recall Z-0506-2020 was initiated by Cook Inc. on September 17, 2019 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated May 21, 2020). Affected quantity: 41 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 27, 2019
- Initiation Date
- September 17, 2019
- Termination Date
- May 21, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 41 units
Product Description
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.
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.
Code Information
Lot 9850522