Class 2 Device Recall Wayne Pneumothorax Tray

• Date Initiated by Firm: September 17, 2019
• Create Date: November 21, 2019
• Recall Status: Terminated on May 21, 2020
• Recall Number: Z-0506-2020
• Recall Event ID: 83921
• Product Classification: Catheter and tip, suction - Product Code JOL
• 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.
• Code Information: Lot 9850522
• Recalling Firm/ Manufacturer: Cook Inc.; 750 N Daniels Way; Bloomington IN 47404-9120
• For Additional Information Contact: Cook Medical Customer Relations Department; 800-457-4500
• Manufacturer 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.
• FDA Determined Cause: Under Investigation by firm
• Action: On September 17, 2019, the firm notified consignees of the recall by mailing Urgent Medical Device Recall letters. The letter alerted customers that if the affected product is used, they may experience increased procedural time to obtain a replacement and local or systemic infection. Customers were asked to take the following actions: 1. Examine inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of this product. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Note: Unaffected products that are returned will not be credited. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected product(s) on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.
• Quantity in Commerce: 41 units
• Distribution: US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.