Z-1865-2017Class II

Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not...

Name: Z-1865-2017 Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not...
Creator: Avid Medical, Inc.
Published: 2017-03-15
License: https://open.fda.gov/license/

Avid Medical, Inc. a Medical Action Ind. Company 305 / initiated 2017-03-15 / Terminated / root cause: manufacturing process

FDA source

Avid Medical, Inc. began a recall of Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing, FEP level testing... on 2017-03-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1865-2017
Classification: Class II
Status: Terminated
Initiated: 2017-03-15
Posted: 2017-04-19
Terminated: 2017-09-07
Recalling firm: Avid Medical, Inc. a Medical Action Ind. Company 305
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.
Product code: OKV Obstetrical Kit
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1865-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1865-2017	Class II	Terminated	Voluntary: Firm initiated	2017-04-26	2017-04-19

Product code OKV

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)