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U.S. Department of Health and Human Services

Class 2 Device Recall Vacutainer Tubes

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  Class 2 Device Recall Vacutainer Tubes see related information
Date Initiated by Firm March 15, 2017
Date Posted April 19, 2017
Recall Status1 Terminated 3 on September 07, 2017
Recall Number Z-1865-2017
Recall Event ID 76745
Product Classification Obstetrical kit - Product Code OKV
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.
Code Information 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 
Recalling Firm/
Manufacturer		 Avid Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information Contact Sharon Moll
757-566-3510
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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