Z-0478-2016Class I

The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set...

Name: Z-0478-2016 The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set...
Creator: Stryker Sustainability Solutions
Published: 2015-11-17
License: https://open.fda.gov/license/

Stryker Sustainability Solutions / initiated 2015-11-17 / Terminated / root cause: design

FDA source

Stryker Sustainability Solutions began a recall of The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and... on 2015-11-17. FDA classified it as Class I and gives the reason as "Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0478-2016
Classification: Class I
Status: Terminated
Initiated: 2015-11-17
Posted: 2016-01-04
Terminated: 2016-09-28
Recalling firm: Stryker Sustainability Solutions
Product: The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtail catheter, access needle, dilator, and wire guide. The set also includes a multipurpose tubing adapter, and three-way stopcock.
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: Stryker Sustainability Solutions is recalling the Fuhrman Pleural & Pneumopericardial Drainage Set due to receiving complaints that it broke off in the pleural cavity while inserting the device into the patient.
Root cause tag: design
FDA root cause: Device Design
Action: The firm, Stryker Sustainability Solutions, sent a "URGENT MEDICAL DEVICE RECALL" letter dated 11/17/2015 to its customers. The letter identified the product, problem, and actions to be taken by the customers. Customers were instructed to discontinue the use of the product, and complete the Recall Effectiveness Check Form even if no product has been found in inventory. Customers should return the completed Recall Effectiveness Check Form to their local Stryker Sustainability Sales Representative, email to [email protected], or mail to: Stryker Sustainability Solutions, 1810 West Drake Drive,Tempe, AZ 85283. If the firm indicates that affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive credit for all affected devices returned. Adverse reactions or quality problems experienced with the use of this product may be reported to: - Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555 - http://www.stryker.com/productexperience/ - The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax. If you have any questions, contact Senior Regulatory Affairs Specialist at (888) 888-3433x5506 or email: [email protected].
Quantity in commerce: 34 devices
Distribution: US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.
Product codes and lots: Item Number G03974 Lot Number 295397U 331621U 374044U 394431U 406125U 406131U 410982U 412655U 415094U 422060U 519812U 7718289U 838193U

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0478-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0478-2016	Class I	Terminated	Voluntary: Firm initiated	2016-01-13	2016-01-04

Product code KDQ

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)