Home / Recalls / Streck / Z-1684-2017

Z-1684-2017 Class II Ongoing

Recalled by Streck — La Vista, NE

Recall Details

Product Type: Devices
Report Date: April 5, 2017
Initiation Date: February 23, 2017
Termination Date: N/A
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 128,692 tubes

Product Description

Cyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0ml only. Packaged 6-tube pack REF 213559 and 100-tube box REF 218980. Streck.

Reason for Recall

Complaints of the 2.0ml tube stopper coming loose during phlebotomy when small diameter tube adapters were not utilized. Such adapters aid with centering small diameter tubes to properly pierce the middle of the stoppers.

Distribution Pattern

Worldwide Distribution - USA (nationwide) and to the countries of : Belgium, Canada, Germany, Israel, Japan, the Republic of Korea, the Netherlands, and the United Kingdom. There was no military or government distribution.

Code Information

UDI Number 10844509000836 and 20844509000833. Lot(s) Expiration Date 50910309 04-01-2017 60760309 03-16-2018 61460309 05-25-2018