Z-0357-06

Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC...

Name: Z-0357-06 Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC...
Creator: Sandhill Scientific, Inc
Published: 2005-12-13
License: https://open.fda.gov/license/

Diversatek Healthcare Inc / initiated 2005-12-13 / Terminated / root cause: labeling and UDI

FDA source

Sandhill Scientific, Inc began a recall of Schuster Anorectal Manometry Probe. Labeling applied to the ballon pouch reads in part: ''SANDHILL SCIENTIFIC SCHUSTER ANORECTAL MANOMETRY PROBE... on 2005-12-13. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0357-06
Status: Terminated
Initiated: 2005-12-13
Posted: 2006-01-06
Terminated: 2006-05-15
Recalling firm: Diversatek Healthcare Inc
Product: 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 labeling found on the pouch reads in part: 'Labeling for the device reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free *** Distributed by: Cardinal Health McGaw Park, IL ***'.
Product code: FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
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.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by letter on 12/13/2005.
Quantity in commerce: 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.
Product codes and lots: Product model # A86-5050. All lot numbers.

Product code FAP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)