FDA Medical Device Recalls (openFDA)
Pascal Co Inc: 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***''
- Recall number
- Z-1588-05
- Recalling firm
- Pascal Co 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***''
- Status
- Terminated
- Initiated
- 2005-08-09
- Posted
- 2005-12-07
- Terminated
- 2011-01-17
- Reason
- 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
- 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
- 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.
- Lot, serial or model codes
- 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,
- 510(k) numbers
- ["K012889"]
- PMA numbers
- not on file
- Product code
- MED
- Firm FEI
- 3011632
- Firm city
- Bellevue
- Firm state
- WA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28