CLASS II Device recall · Reported 26 Apr 2017 · FDA Enforcement Report
Vacutainer Tubes Vacutainer tubes are intended recalled by Avid Medical
Avid Medical is recalling Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies. The recall was initiated on 15 Mar 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1865-2017
- FDA event ID
- 76745
- Recalling firm
- Avid Medical, Toano, VA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Mar 2017
- FDA classified
- 19 Apr 2017
- Reported
- 26 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Lead & Heavy Metals
- Device type
- Other Medical Devices
Timeline
| 15 Mar 2017 | Recall initiated by company | |
| 19 Apr 2017 | Classified by FDA | +35 days |
| 26 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
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.
Where it was 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.
Questions about this recall
Is Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies recalled?
Yes. Avid Medical recalled Vacutainer Tubes Vacutainer tubes are intended for clinical laboratory hematology studies on 15 Mar 2017. The recall is Class II and its status is Terminated. Recall number Z-1865-2017.
Why was it 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.
Which lots are affected?
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
Where was it sold?
All products are distributed through distribution centers confined to the US. All end-users for these products are also solely located in the US.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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