Cook Inc.: Medical Device Recall in 2019 - (Recall #: Z-0506-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 17, 2019

Date Posted: November 27, 2019

Recall Number: Z-0506-2020

Event ID: 83921

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.

Status: Terminated

Product Quantity: 41 units

Code Information:

Lot 9850522

Distribution Pattern:

US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.

Voluntary or Mandated:

Voluntary: Firm initiated