| Class 2 Device Recall Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device | |
Date Initiated by Firm | June 27, 2011 |
Date Posted | July 15, 2011 |
Recall Status1 |
Terminated 3 on March 20, 2012 |
Recall Number | Z-2831-2011 |
Recall Event ID |
59184 |
Product Classification |
Sheath, Corrugated rubber, for nonindwelling catheter - Product Code NNY
|
Product | Rusch, Sure Seal Golden Drain, One Piece Urinary Incontinence Device, Teleflex Medical.
Used for urine collection. |
Code Information |
Catalog number: A1300VA, Lot number: 02E1002552 Catalog number: A1300, Lot number: 02F1001467, 02F1002271, 02F1003283, 02G1000845 and 02G1001302. |
Recalling Firm/ Manufacturer |
Teleflex Medical 4024 Stirrup Creek Dr Durham NC 27703-9000
|
For Additional Information Contact | Robert Phillips 610-378-0131 |
Manufacturer 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. |
FDA Determined Cause 2 | Other |
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. |
Quantity in Commerce | 6880 units (total for both products) |
Distribution | Nationwide Distribution (USA) including the states of FL, GA, OH and SC. |
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.
|
|
|
|