Avid Medical, Inc.: 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.

Recall number

Z-1865-2017

Recalling firm

Avid Medical, Inc.

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.

Status

Terminated

Initiated

2017-03-15

Posted

2017-04-19

Terminated

2017-09-07

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.

Root cause

Employee error

Action

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.

Quantity

25308

Distribution

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

Lot, serial or model codes

Part Number/Product Number  ILEY029-01 ULKY005-14 LOUS015-03 DNAZ017-01  ILEY029-02 SERA003-07 TENN016-05 DONS008-05 EVER007 SERA005-07 LANC029-06 STLM007-10 CCHM024-03  Part Number/Product Number  LANC015-27 CCHM027-04 STLM003-11 ABIN137-01 ABIN110-01 LANC015-28 MONT045-03 ILEY003-53 NAFB015-07 ILEY014-21 ILEY034-04 ILEY034-05  Part Number/Product Number  AV10654-10 ILEY014-22 EVER010 EVER001 SOHS016-03 SSHH118-03 SSHH117-06 SOHS017-03 HCMH009-05 WIME023-08 TUFT040-05  Part Number/Product Number  TUFT039-08 HCMH009-06 GIFT022-01 TUFT040-06 PCHM004-07 HLDH008-04 WHWC005-17 PCHM008-04 LANC015-25 PCHM011-03

510(k) numbers

not on file

PMA numbers

not on file

Product code

OKV

Firm FEI

1047429

Firm city

Toano

Firm state

VA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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