Z-0252-2020 Class II Terminated

Recalled by Becton Dickinson & Company — Franklin Lakes, NJ

FDA device recall Z-0252-2020 was initiated by Becton Dickinson & Company on March 7, 2019 and is designated Class II. Reason for recall: BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage. The recall status is terminated (terminated February 11, 2022). Affected quantity: 2,624,160 (2,169,703 US; 454,457 OUS).

Recall Details

Product Type
Devices
Report Date
November 6, 2019
Initiation Date
March 7, 2019
Termination Date
February 11, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2,624,160 (2,169,703 US; 454,457 OUS)

Product Description

BD Vacutainer Eclipse Blood Collection Needles 22Gx1.25, cat. no. 368608

Reason for Recall

BD PAS received customer complaints indicating the absence of the bevel on the non-patient needle end of the product, causing blood leakage.

Distribution Pattern

Distributed to accounts in AR, CT, FL, IL, IN, MI, MO, MS, NY, OH, TN, TX, and VA. Foreign distribution to Canada, Brazil, India, Mexico, Singapore, and Taiwan.

Code Information

Lot 8207894 ***UPDATED 7/11/19*** Lots 9025826 and 8354527 ***UPDATED 12/10/19*** Lot 9010765