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***''
This recall has been terminated (originally issued December 7, 2005).
- Company
- Pascal Co Inc
- Recall Initiated
- August 9, 2005
- Posted
- December 7, 2005
- Terminated
- January 17, 2011
- Recall Number
- Z-1588-05
- Quantity
- 89,922 units (each unit is one gallon)
- Firm Location
- Bellevue, WA
- Official Source
- View on FDA website ↗
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.
Distribution
To dental product distributors nationwide and to 1 dental product distributor in Israel. Also directly to dental offices nationwide.
Lot / Code Info
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,
Root Cause
Other
Action Taken
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.