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U.S. Department of Health and Human Services

Class 2 Device Recall Banicide Advanced

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  Class 2 Device Recall Banicide Advanced see related information
Date Initiated by Firm August 09, 2005
Date Posted December 07, 2005
Recall Status1 Terminated 3 on January 17, 2011
Recall Number Z-1588-05
Recall Event ID 32900
510(K)Number K012889  
Product Classification Sterilant, Medical Devices - Product Code MED
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***''
Code Information 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, 
Recalling Firm/
Manufacturer		 Pascal Co Inc
2929 N E Northup Way
P.O. Box 1478
Bellevue WA 98004
For Additional Information Contact Vincent M. Tentarelli
425-602-3633
Manufacturer 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.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MED and Original Applicant = PASCAL CO., INC.
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