| ||Class 1 Device Recall The Fuhrman Pleural/Pneumopericardial Drainage Set |
||January 04, 2016
|Recall Event ID
Bottle, collection, vacuum -
||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.
Stryker Sustainability Solutions
10232 S 51st St
|For Additional Information Contact
888-888-3433 Ext. 5506
|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.
||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@example.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
- 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: firstname.lastname@example.org.
|Quantity in Commerce
||US Distribution in the states of: AK, CA, WI, IN, FL, OR, NY, and NC.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.