FDA Device recall Z-1865-2017
Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing,…
- FDA Device
- Class II
- terminated
- Published 2017-04-26
On 2017-04-26 the FDA classified a Class II recall of Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies including but not limited to lead level testing,… by Avid Medical, citing 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 label….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1865-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-03-15 |
| Published | 2017-04-26 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Avid Medical |
| Distribution | n/a |
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.
Identifiers
| code_info | Part Number/Product Number ILEY029-01 ULKY005-14 LOUS015-03 DNAZ017-01 ILEY029-02 SERA003-07 TENN016-05 DON…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1865-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.