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U.S. Department of Health and Human Services

Class 2 Device Recall Anorectal Manometry Probe

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  Class 2 Device Recall Anorectal Manometry Probe 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-0356-06
Recall Event ID 34198
510(K)Number K931175  
Product Classification Cystometric Gas (Carbon-Dioxide) On Hydraulic Device - Product Code FAP
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: A86-4050. *** Size: Adult ... CAUTION: Balloon are made of latex rubber. *** Do not use if latex sensitivity exists.' Additional labeling found on the pouch reads in part: 'Cat. 92510 Convertors Self-Seal Pouch 51/4'x10' *** Latex Free*** Distributed by: Cardinal Health McGaw Park, IL***.'
Code Information Product model # A86-4050. All lot numbers.
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		 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.
FDA Determined
Cause 2		 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.
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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