Device Recall Vacutainer Tubes 의 리콜

Recall

76745

Class 2

Z-1865-2017

2017-03-15

2017-04-19

Terminated

United States

2017-09-07

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154076

Avid medical inc has received a complaint was received from an end-user indicating the vacutainer component 519700 (bd: 367863) expiring 12/16 was discovered inside of a kit labelled with an expiration date after 12/16. upon receipt of complaint, avid medical promptly initiated an internal investigation and root cause analysis. investigation found mixed component lots were contained in product 519700 component case. this occurrence resulted in the incorrect lot number and expiration being attributed to all work orders produced using the affected component. this issue was immediately contained and corrected. a full inventory analysis was conducted reviewing all vacutainer component inventories. the issue was found to affect a total of five vacutainer components.

Avid Medical has identified all impacted products along with distribution centers and end-users as addressed in the tables supplied within this notification. An urgent medical device notice of correction will be issued to alert end-users about the inaccurate expiration date on convenience kits containing the vacutainer component(s) (See attachment). A correction response form will be used to effectively manage all distributer/end-user confirmation of required actions (See attachment). Avid Medical will make three attempts to confirm appropriate actions have been taken and acknowledged by each distributer/end-user for all affected product remaining in inventory. End-users will be provided a label template or actual labels to affix to kits in their inventory to alert users to confirm the vacutainer component expiration date prior to component use. Replacement vacutainer components will be offered for accompanied use with the affected kits. Execution of the correction will be conducted with direct oversight of the associated Avid Medical account representative. Avid Medical has determined that a notification /correction is appropriate because the convenience kits are critical and customized to hospital needs. Most of the impacted kits are sterile and are built in a configuration which is customized to hospital operating procedures according to each hospitals indicated requirements; therefore, new kit production and rework of affected kits would result in lack of critical supplies for the affected end-users.