—#176746

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.

FDA product code: JOL — Catheter And Tip, Suction
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Lot 9850522

Why it was 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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Cook Inc.
Address: 750 N Daniels Way, Bloomington, Indiana 47404-9120

Distribution

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

Timeline

Recall initiated: 2019-09-17
Terminated: 2020-05-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #176746. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.