Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number f
FDA device recall Z-0359-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Sandhill Scientific, Inc
- Reason for recall
- Labeling does not indicate that the product contains latex.
- Action taken
- All consignees were notified by letter on 12/3/05. Canadian consignees were re-notified on December 14, 2005 by letter.
- Root cause
- Other
- Status
- Terminated
- Product code
- FAP
- Quantity affected
- 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, Malays
- Date initiated
- 2005-12-13
- Date posted
- 2006-01-06
- Date terminated
- 2006-05-15
- Location
- Highlands Ranch, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SCHUSTER DISPOSABLE BALLOON PROBE (K931175) | Sandhill Scientific, Inc. | 1994-04-01 |