Z-0359-06

Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the...

Name: Z-0359-06 Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the...
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 Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products on 2005-12-13. The reason FDA records is "Labeling does not indicate that the product contains latex". 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-0359-06
Status: Terminated
Initiated: 2005-12-13
Posted: 2006-01-06
Terminated: 2006-05-15
Recalling firm: Diversatek Healthcare Inc
Product: Replacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
Product code: FAP Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
Reason for recall: Labeling does not indicate that the product contains latex.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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.
Product codes and lots: All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.

Product code FAP

K931175Class IISchuster Disposable Balloon ProbeSandhill Scientific, Inc. / cleared 1994-04-01

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)