Pressure Tourniquet Cuffs 의 리콜

Recall

75221

Class 2

Z-0324-2017

2016-09-19

Terminated

United States

2017-06-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149691

Issue with the process for detection of leaking pressure tourniquet cuffs (ptc). leaking ptc devices may result in excessive blood loss requiring surgical or medical intervention or systemic leakage of local anesthetic during bier block requiring medical intervention.

Stryker Sustainability Solutions sent an Customer Notification letter September 19, 2016. Customers were instructed to discontinue use of the affected products. The letter stated to follow the link below to complete the Recall Effectiveness Check Form and indicate if any devices containing expiration dates from May 2016-May 2018 remain in inventory. This form must be completed even if no affected product is found. Use the following reference number as you complete the form: [Ship to Account #] If the form indicates that any affected devices remain in inventory, a prepaid shipping label will be issued for the return of the product. Credit for all affected devices returned will be issued to the facility. .Adverse reactions or quality problems experienced with the use of this product may be reported to: o Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433 X5555 o http://www.stryker.com/productexperience/ o The FDAs MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.