FDA-Device2014-11-12Class II

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

Dokitz NovoSci
Hazard

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

Sold states
MO, TX, PA, IL, MD, UT
Affected count
240 units
Manufactured in
2021 Airport Rd, N/A, Conroe, TX, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0178-2015

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