Retiro De Equipo (Recall) de Mallinckrodt Launcher Guiding Catheter

Recall

73835

Class 2

Z-1626-2016

2016-04-04

Terminated

United States

2016-07-13

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=145080

Device packaging may not be sealed.

Customer notification letter was sent 04/04/2016. The customer was provided the following instructions: Use of the affected lots of the recalled product should be discontinued. A Recall Effectiveness Check Form has been enclosed. Note that the recall is limited to the specific lot number shipped to facility. Once inventory has been checked complete the Recall Effectiveness Check Form. The form needs to be completed even if no affected product is found. Return the completed and signed Recall Effectiveness Check Form utilizing one of the following methods: Return to your local Stryker Sustainability Sales Representative Email to ssspfa@stryker.com, or Mail to: Stryker Sustainability Solutions 181 O West Drake Drive Tempe, AZ. 85283 Attn: Jodie Rueckert If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Customers will receive a 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 FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.