FDA Medical Device Recalls (openFDA)
Dokitz NovoSci: 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
- Recall number
- Z-0178-2015
- Recalling firm
- Dokitz NovoSci
- 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
- Status
- Terminated
- Initiated
- 2014-09-18
- Posted
- 2014-11-06
- Terminated
- 2015-05-15
- Reason
- The single leg of the PAY connector has been observed to become detached.
- Root cause
- Process control
- Action
- The recalling firm notified the affected customers via letter and requested the affected lot be returned to NovoSci.
- Quantity
- 240 units
- Distribution
- MO, TX, PA, IL, MD, UT
- Lot, serial or model codes
- Model No. 321334-000, lot number 295424
- 510(k) numbers
- ["K801404"]
- PMA numbers
- not on file
- Product code
- DTL
- Firm FEI
- 1625519
- Firm city
- Conroe
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28