RecallRadar

FDA Device recall Z-0178-2015

Cardiopulmonary bypass connector

On 2014-11-12 the FDA classified a Class II recall of Cardiopulmonary bypass connector by Dokitz Novosci, citing the single leg of the PAY connector has been observed to become detached.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0178-2015
ClassificationClass II
Statusterminated
Initiated2014-09-18
Published2014-11-12
Last updated2026-09-13 11:53 UTC
CompanyDokitz Novosci
DistributionIL, MD, MO, PA, TX, UT

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.

Identifiers

code_infoModel No. 321334-000, lot number 295424

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0178-2015%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.