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Terminated

Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical. Used for urine collection.

FDA Recall Z-2831-2011 · Posted 2011-07-15

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeNNY
Date Initiated2011-06-27
Date Terminated2012-03-20
Product Quantity6880 units (total for both products)

Reason for Recall

The Kit contains Skin-Prep protective wipes that were manufactured by the Triad Group and are being recalled by Smith & Nephew, due to possible bacterial contamination.

Firm Action

Teleflex Medical sent an "Urgent Medical Device Recall Notification" dated June 27, 2011 to all affected customers. The firm provided recommendations including all affected product be discontinued and quarantined. A Recall Acknowledgement Form was provided to be completed and returned. If the product was further distributed, they were urged to contact their customers and communicate the recall. For additional information please contact Customer Service at 866-246-6990 or your local sales representative.

Root Cause

Other

Distribution Pattern

Nationwide Distribution (USA) including the states of FL, GA, OH and SC.

Official Source

View FDA Recall →

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

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