Recall Z-0357-06 ยท FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Sandhill Scientific, Inc
Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE Rectosphincteric Manometry Balloon Probe Manufactured by: SANDHILL SCIENTIFIC, INC. HIGHLANDS RANCH, COLORADO USA P/N: A86-5050. *** Size: Pediatric... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional
| Date | Jan 6, 2006 (initiated Dec 13, 2005) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | Consignees were notified by letter on 12/13/2005. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.