Recall Z-1588-05 ยท MED Sterilant, Medical Devices
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***''
| Date | Dec 7, 2005 (initiated Aug 9, 2005) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K012889 | BANICIDE LIQUID CHEMICAL STERILANT/HIGH-LEVEL DISINFECTANT Pascal Co., Inc., May 27, 2003 |