Z-0902-2013Class II

Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and...

Name: Z-0902-2013 Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and...
Creator: Salyer Prn Biomedical
Published: 2013-01-31
License: https://open.fda.gov/license/

Century HLM, LLC / initiated 2013-01-31 / Terminated

FDA source

Salyer Prn Biomedical began a recall of Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical... on 2013-01-31. FDA classified it as Class II and gives the reason as "Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0902-2013
Classification: Class II
Status: Terminated
Initiated: 2013-01-31
Posted: 2013-03-01
Terminated: 2013-04-15
Recalling firm: Century HLM, LLC
Product: Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Product code: DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Reason for recall: Concerns that the addition of the UPS Battery Backup to the Century Console Base Shelf did not comply with the FDA premarket notification regulations.
FDA root cause: No Marketing Application
Action: An Urgent: Medical Device Recall letter, dated 1/31/13, was sent to all the customers that received the Century Console Base Shelf option with the Linear/1.5k 115v UPS Battery Backup for the Century Heart Lung Machine. The letter informed the customers that Salyer PRN Biomedical will have a Salyer Biomedical technician return the customers' Century Console Bases to their original configuration without the Shelf option and restore the Linear/1.5k UPS Battery Backup to its original condition as a stand-alone unit with its own wheel base for ease of use. A refund or credit will be issued for the return of the product. Customers are instructed to contact Jeff Poland at (314) 497-5232.
Quantity in commerce: 9 units
Distribution: Distributed in the states of MA,CA, and WI.
Product codes and lots: Serial Numbers: CCB40120, CCB40121, CCB40122, CCB40123, CCB40124, CCB40139, CCB40140, CCB40143, and CCB40144.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0902-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0902-2013	Class II	Terminated	Voluntary: Firm initiated	2013-03-13	2013-03-01

Product code DTQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)