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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 Firm December 13, 2005
Date Posted January 06, 2006
Recall Status1 Terminated 3 on May 15, 2006
Recall Number Z-0359-06
Recall Event ID 34222
510(K)Number K931175  
Product Classification Cystometric Gas (Carbon-Dioxide) On Hydraulic Device - Product Code FAP
Product Replacement 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.
Recalling Firm/
Manufacturer		 Sandhill Scientific, Inc
9150 Commerce Center Cir Ste 500
Highlands Ranch CO 80129-1563
For Additional Information Contact Guy Harris
303-470-7020
Manufacturer Reason
for Recall		 Labeling does not indicate that the product contains latex.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = FAP and Original Applicant = SANDHILL SCIENTIFIC, INC.
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