Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-2584-2017Class II

Palcam Supplement Acumedia PN 7987

Neogen Culture Media / initiated 2015-11-30 / Terminated / root cause: manufacturing process

Acumedia Manufacturers, Inc. began a recall of Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential... on . FDA classified it as Class II and gives the reason as "Contamination of product with possible Bacillus spp". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2584-2017
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Neogen Culture Media
Product
Palcam Supplement Acumedia PN 7987 Product Usage: PALCAM Supplement is used with PALCAM Agar or PALCAM Broth as a supplement for the selective and differential enrichment of Listeria spp. From foods, dairy and environmental samples.
Product code
JSI Culture Media, Selective And Differential
Reason for recall
Contamination of product with possible Bacillus spp
Root cause tag
manufacturing process
FDA root cause
Process design
Action
On 11/30/2015 and 1/21/2016, notifications were sent to the affected consignees via e-mail. The recall notification included a description of the reason for the recall, affected product, and offers replacement product.
Quantity in commerce
28 units
Distribution
Worldwide Distribution - US Nationwide in the states of WI, NJ, NY and countries of BRAZIL, ECUADOR, SINGAPORE, CANADA,
Product codes and lots
PN 7987, Lot 108044

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2584-2017
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2584-2017Class IITerminatedVoluntary: Firm initiated