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

FDA device recall Z-2831-2011 · posted 2011-07-15 · Terminated

Recall details

Recalling firm

Teleflex Medical

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.

Action taken

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

Status

Terminated

Product code

NNY

Quantity affected

6880 units (total for both products)

Distribution

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

Date initiated

2011-06-27

Date posted

2011-07-15

Date terminated

2012-03-20

Location

Durham, NC