The Fuhrman Pleural/Pneumopericardial Drainage Set The Fuhrman Pleural/Pneumopericardial Drainage Set consists of pigtai

FDA device recall Z-0478-2016 · posted 2016-01-04 · Terminated

Recall details

Recalling firm

Stryker Sustainability Solutions

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.

Action taken

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 ssspfa@stryker.com, 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: chelsea.cullen@stryker.com.

Root cause

Device Design

Status

Terminated

Product code

KDQ

Quantity affected

34 devices

Distribution

US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.

Date initiated

2015-11-17

Date posted

2016-01-04

Date terminated

2016-09-28

Location

Phoenix, AZ