Remel Middlebrook 7H10 Agar, Ref R01600, packaged 10 units/package. The firm name on the label is Remel, Lenexa, KS. Sol

FDA device recall Z-1733-2009 · posted 2009-08-14 · Terminated

Recall details

Recalling firm

Remel, Inc

Reason for recall

The plate labeling is incorrect, but the outer box labeling is correct

Action taken

The recalling firm issued Important Medical Device Customer Recall Notice letters dated 5/6/08 via regular mail explaining the reason for recall and requesting all remaining inventory of the recalled lot be discarded. A Product Inventory Checklist was enclosed for completion to report the amount of inventory destroyed. A self-addressed postage-paid envelope was enclosed for return of the Product Inventory Checklist. Customers are to contact the firm's Technical Services Department at 800-447-3641 if they have inquiries concerning the letter.

Root cause

Error in labeling

Status

Terminated

Product code

JSY

Quantity affected

118 packages

Distribution

Nationwide Distribution -- including states of FL, NJ, IN, FL, OH, KY, TX, and WI.

Date initiated

2009-05-06

Date posted

2009-08-14

Date terminated

2009-10-15

Location

Lenexa, KS