Z-0178-2015 Class II Terminated
FDA device recall Z-0178-2015 was initiated by Dokitz NovoSci on September 18, 2014 and is designated Class II. Reason for recall: The single leg of the PAY connector has been observed to become detached. The recall status is terminated (terminated May 15, 2015). Affected quantity: 240 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 12, 2014
- Initiation Date
- September 18, 2014
- Termination Date
- May 15, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240 units
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.
Distribution Pattern
MO, TX, PA, IL, MD, UT
Code Information
Model No. 321334-000, lot number 295424