FDA recall Z-0506-2020

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.

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

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

Key facts

Status

Terminated

Initiation date

2019-09-17

Report date

2019-11-27

Termination date

2020-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0506-2020