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U.S. Department of Health and Human Services

Class 1 Device Recall The Fuhrman Pleural/Pneumopericardial Drainage Set

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  Class 1 Device Recall The Fuhrman Pleural/Pneumopericardial Drainage Set see related information
Date Initiated by Firm November 17, 2015
Date Posted January 04, 2016
Recall Status1 Terminated 3 on September 28, 2016
Recall Number Z-0478-2016
Recall Event ID 72715
Product Classification Bottle, collection, vacuum - Product Code KDQ
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.
Code Information Item Number G03974  Lot Number 295397U 331621U 374044U 394431U 406125U 406131U 410982U 412655U 415094U 422060U 519812U 7718289U 838193U
Recalling Firm/
Manufacturer		 Stryker Sustainability Solutions
10232 S 51st St
Phoenix AZ 85044-5205
For Additional Information Contact Chelsea Cullen
888-888-3433 Ext. 5506
Manufacturer 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.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 34 devices
Distribution US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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