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Terminated

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

FDA Recall Z-0178-2015 · Posted 2014-11-06

Recalling FirmDokitz NovoSci
Recall StatusTerminated
Product CodeDTL
Date Initiated2014-09-18
Date Terminated2015-05-15
Product Quantity240 units

Reason for Recall

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

Firm Action

The recalling firm notified the affected customers via letter and requested the affected lot be returned to NovoSci.

Root Cause

Process control

Distribution Pattern

MO, TX, PA, IL, MD, UT

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K801404DISPOSABLE PARALLEL Y CONNECTORSTexas Medical Products, Inc. · 1980-06-30

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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