Recall Z-0178-2015— Dokitz NovoSci

Name: FDA recall Z-0178-2015
Creator: U.S. Food and Drug Administration
Published: 2014-09-18

Class II · Terminated

Class II FDA medical device recall by Dokitz NovoSci, initiated 2014-09-18, terminated 2015-05-15. It names one FDA 510(k) clearance: K801404. Product: Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014. Reason: The single leg of the PAY connector has been observed to become detached..

Recalling firm: Dokitz NovoSci
Classification: Class II
Status: Terminated
Initiated: 2014-09-18
Terminated: 2015-05-15
Firm location: Conroe, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K801404 — DISPOSABLE PARALLEL Y CONNECTORSTexas Medical Products, Inc.·cleared 1980-06-30

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Cardiopulmonary bypass connector; P/N: 321334-000 DESC: CONNECTOR, 3/8 X 3/8 X 1/2 CLEAR PAY LOT: 295424 STERILE Expiration May 2019 Manufacturing Date May 2014

Reason for recall

The single leg of the PAY connector has been observed to become detached.

Data sourced from openFDA. This site is unofficial and independent of the FDA.