Z-1588-05

product labeled in part: ''banicide ADVANCED, A Reusable Sterilizing & Disinfecting SolutionActive...

Name: Z-1588-05 product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active...
Creator: Pascal Co Inc
Published: 2005-08-09
License: https://open.fda.gov/license/

Pascal International, Inc. / initiated 2005-08-09 / Terminated / root cause: sterility

FDA source

Pascal Co Inc began a recall of product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial)... on 2005-08-09. The reason FDA records is "The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1588-05
Status: Terminated
Initiated: 2005-08-09
Posted: 2005-12-07
Terminated: 2011-01-17
Recalling firm: Pascal International, Inc.
Product: product labeled in part: ''***banicide ADVANCED, A Reusable Sterilizing & Disinfecting Solution***Active Ingredient: Glutaraldehyde (1,5 Pentanedial) 3.5%***NET CONTENTS: 3.8l (ONE U.S. GALLON)***Manufactured by Pascal Company, Inc. 2929 N.E. Northup Way P.O. Box 1478 Bellevue, WA 98009-1478 USA***''
Product code: MED Sterilant, Medical Devices
Reason for recall: The product, Banicide Advanced, a resuable sterilizing and disinfecting solution, is likely to be ineffective for its intended use because testing found it failed testing for sporicidal use.
Root cause tag: sterility
FDA root cause: Other
Action: On August 10, 2005 the firm began notifying consignees via phone and began follow up with notification letters on August 12, 2005. Consignees are being asked to return product. The firm subsequently extended its recall after lots manufactured in June 2005 were tested by FDA and failed the sporicidal testing. The firm identified recipients of the affected product and began to contact them by phone on October 3, 2005. The firm began follow-up notification via mail on October 6, 2005. All customers are requested to respond directly to Pascal regarding disposition of any remaining product.
Quantity in commerce: 89,922 units (each unit is one gallon)
Distribution: To dental product distributors nationwide and to 1 dental product distributor in Israel. Also directly to dental offices nationwide.
Product codes and lots: the following 3 codes were recalled initially: (LOT EXP 110305, LOT EXP 110605, LOT EXP 110705) On October 3, 2005 the firm expanded the recall to include all product produced between October 2004 through August 2005. Following are all the recalled lot codes. 100105, 100205, 100305, 100405, 100505, 100605, 110105, 110205, 110305, 110405, 110505, 110605, 110705, 120105, 120205, 120305, 010106, 010206, 010306, 010406, 010506, 020106, 020206, 020306, 020406, 020506, 020606, 020706, 020806, 030106, 030206, 030306, 030406, 030506, 030606, 030706, 030806, 030906, 031006, 031106, 040106, 040206, 040306, 050106, 050206, 050306, 050406, 060106, 060206, 060306, 060406, 060506, 070106, 070206, 070306, 070406, 080106,

Product code MED

K012889Class IIBanicide Liquid Chemical Sterilant/high-Level DisinfectantPascal Co., Inc. / cleared 2003-05-27

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)