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Terminated

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***.'

FDA Recall Z-0356-06 · Posted 2006-01-06

Recalling FirmSandhill Scientific, Inc
Recall StatusTerminated
Product CodeFAP
Date Initiated2005-12-13
Date Terminated2006-05-15
Product Quantity4342 probes total for both sizes.

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.

Firm Action

Consignees were notified by letter on 12/13/2005.

Root Cause

Other

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K931175SCHUSTER DISPOSABLE BALLOON PROBESandhill Scientific, Inc. · 1994-04-01

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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