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Terminated

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

FDA Recall Z-0359-06 · Posted 2006-01-06

Recalling FirmSandhill Scientific, Inc
Recall StatusTerminated
Product CodeFAP
Date Initiated2005-12-13
Date Terminated2006-05-15
Product Quantity2358 Probes

Reason for Recall

Labeling does not indicate that the product contains latex.

Firm Action

All consignees were notified by letter on 12/3/05. Canadian consignees were re-notified on December 14, 2005 by letter.

Root Cause

Other

Distribution Pattern

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.

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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