Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER A
FDA device recall Z-0356-06 · posted 2006-01-06 · Terminated
Recall details
- Recalling firm
- Sandhill Scientific, Inc
- Reason for recall
- The product is mislabeled. The labeling on the front of the packaging states that product contains latex. However, the back of the package contains a latex- free symbol.
- Action taken
- Consignees were notified by letter on 12/13/2005.
- Root cause
- Other
- Status
- Terminated
- Product code
- FAP
- Quantity affected
- 4342 probes total for both sizes.
- Distribution
- CA, CO, GA, KS, LA, IN, IL, ID, IA, MD, MO, NE, NJ, NM, OR, PA, TN, TX, VA, VT, WA, WV. Military hospitals in CA and CO. Foreign distribution to Egypt, Netherlands.
- 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 |