Avid Medical product recalled over lead risk

Recall date

March 15, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Avid Medical, Inc. recalls Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to…

Recall number

Z-1865-2017

FDA classification

Class II

Brand / firm

Avid Medical, Inc.

Sold / distributed

All products are distributed through distribution centers confined to the US. All end-users for these products are also solely located in the US.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.