Recall Z-0359-06 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Sandhill Scientific, Inc
Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
| Date | Jan 6, 2006 (initiated Dec 13, 2005) |
| Status | Terminated |
| Reason | Labeling does not indicate that the product contains latex. |
| Root cause | Other |
| Action | All consignees were notified by letter on 12/3/05. Canadian consignees were re-notified on December 14, 2005 by letter. |
| Quantity | 2358 Probes |
| Distribution | Distributed nationwide including PR. Military distibution in MD and TX. Veteran Affairs facilities located in AR, CO, CT, HI, and NC. Foreign distribution includesTaiwan, Saudi Arabia, England, Malaysia, Korea, Chile, Venequela, China, and Brazil. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K931175 | SCHUSTER DISPOSABLE BALLOON PROBE Sandhill Scientific, Inc., Apr 1, 1994 |