Z-0506-2020Class II

Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 -

Name: Z-0506-2020 Pneumothorax Tray, Catalog No. C-UTPTY-1400-WAYNE-112497-IMH, GPN G56537 -
Creator: Cook Inc.
Published: 2019-09-17
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-09-17 / Terminated / root cause: packaging

FDA source

Cook Inc. began a recall of 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... on 2019-09-17. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0506-2020
Classification: Class II
Status: Terminated
Initiated: 2019-09-17
Posted: 2019-11-21
Terminated: 2020-05-21
Recalling firm: Cook Incorporated
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.
Product code: JOL Catheter And Tip, Suction
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.
Root cause tag: packaging
FDA root 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 ([email protected]). 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: [email protected].
Quantity in commerce: 41 units
Distribution: US Nationwide distribution in the states of CA, FL, IN, MI, MT, NC, NY, OH.
Product codes and lots: Lot 9850522

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0506-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0506-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-27	2019-11-21

Product code JOL

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)