Device Recall SMART PERFUSION PACK, SMART 3/16" PEDS PACK 의 리콜

Recall

77810

Class 2

Z-2790-2017

2017-06-29

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=157947

Medtronic informed livanova that some of their dlp pressure disposable display sets are packaged in pouches which may have small pinholes (approximately 1mm or less in diameter). the result is a potential sterile barrier breach in the display sets. these display sets are included with livanova perfusion tube sets (pts) which were then distributed to customers.

The firm initiated their recall verbally on 06/29/2017 and following with letters mailed on 07/13/2017. The actions to be taken by the customer: 1. Notify staff to not use the Medtronic labeled device contained within the LivaNova Perfusion Tube Set packs. 2. If the set is a standalone component within the pack, remove the device upon opening the pack at the time of the procedure. 3. If the device is connected to the circuit, remove the device and attach a new unit upon opening the pack. 4. Identify the Medtronic device with one of the barcode pack labels attached to the lidstock of the LivaNova perfusion pack. 5. Collect the devices for return to LivaNova until all affected perfusion sets have been consumed. In order to assist in controlling inventory, the LivaNova sales representative will have labels available to identify packs containing the affected devices. 6. Contact LivaNova Customer Support at (800) 650-2623 (M-F 8AM to 5PM MT) to arrange for the return of the affected product, and to order equivalent replacement product.