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.
Reported: November 27, 2019 Initiated: September 17, 2019 #Z-0506-2020
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.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 41 units
- Distribution
- US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Inc.. Units affected: 41 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 27, 2019. Severity: Moderate. Recall number: Z-0506-2020.
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