Recall Z-1865-2017— Avid Medical, Inc.

Class II FDA medical device recall by Avid Medical, Inc., initiated 2017-03-15, terminated 2017-09-07. FDA's recall record names no specific 510(k) clearance for this event. Product: Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing, and CBC testing.. Reason: 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..

Recalling firm

Avid Medical, Inc.

Classification

Class II

Status

Terminated

Initiated

2017-03-15

Terminated

2017-09-07

Firm location

Toano, VA, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.