Z-1725-2019Class II

Thoracentesis Set, RPN C-THS-850, Order # G03286

Name: Z-1725-2019 Thoracentesis Set, RPN C-THS-850, Order # G03286
Creator: Cook Inc.
Published: 2019-04-09
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2019-04-09 / Terminated / root cause: manufacturing process

FDA source

Cook Inc. began a recall of Thoracentesis Set, RPN C-THS-850, Order # G03286 on 2019-04-09. FDA classified it as Class II and gives the reason as "Affected products may have been manufactured with the catheter distal end hole too small". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1725-2019
Classification: Class II
Status: Terminated
Initiated: 2019-04-09
Posted: 2019-06-04
Terminated: 2020-04-28
Recalling firm: Cook Incorporated
Product: Thoracentesis Set, RPN C-THS-850, Order # G03286
Product code: PYC Paracentesis Tray
Reason for recall: Affected products may have been manufactured with the catheter distal end hole too small
Root cause tag: manufacturing process
Action: On April 9, 2019 Cook Medical issued URGENT MEDICAL DEVICE RECALL notices to customers via courier service. Customers were advised to take the following Actions: 1. Examine your inventory immediately to determine if you have affected product(s), and quarantine affected product(s). Immediately cease all distribution and use of these products. 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. Complete and return 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 it via fax (812.339.7316) or by email to [email protected]. 4. The 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 7:30 am and 5:00 pm (Eastern Time) or by email to [email protected].
Quantity in commerce: 5 units
Distribution: Domestically: OH; Internationally: CANADA, SPAIN, ITALY, BELGIUM, GERMANY, UNITED ARAB EMIRATES, GREECE, SWITZERLAND, OMAN, MONACO, SAUDI ARABIA, AUSTRALIA, HONG KONG, INDIA & KOREA
Product codes and lots: Lot Number NS7662071

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1725-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1722-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1723-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1724-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04
Z-1725-2019	Class II	Terminated	Voluntary: Firm initiated	2019-06-12	2019-06-04

Product code PYC

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)