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U.S. Department of Health and Human Services

Class 2 Device Recall Replacement balloons for use with Sandhill Anorectal Manometry Probes.

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 Class 2 Device Recall Replacement balloons for use with Sandhill Anorectal Manometry Probes.see related information
Date Initiated by FirmDecember 13, 2005
Date PostedJanuary 06, 2006
Recall Status1 Terminated 3 on May 15, 2006
Recall NumberZ-0359-06
Recall Event ID 34222
510(K)NumberK931175 
Product Classification Cystometric Gas (Carbon-Dioxide) On Hydraulic Device - Product Code FAP
ProductReplacement balloons for use with Sandhill Anorectal Manometry Probes. There is no labeling other than the part number for these products.
Code Information All replacement balloons. For use on probe models AB1, PB1, A86-1067, A86-1067-1, A86-5067, A86-5070 and A86-5050.
FEI Number 2023374
Recalling Firm/
Manufacturer		 Sandhill Scientific, Inc
9150 Commerce Center Cir Ste 500
Highlands Ranch CO 80129-1563
For Additional Information ContactGuy Harris
303-470-7020
Manufacturer Reason
for Recall		Labeling does not indicate that the product contains latex.
FDA Determined
Cause 2		Other
ActionAll consignees were notified by letter on 12/3/05. Canadian consignees were re-notified on December 14, 2005 by letter.
Quantity in Commerce2358 Probes
DistributionDistributed 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FAP
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