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U.S. Department of Health and Human Services

Class 2 Device Recall Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter

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  Class 2 Device Recall Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter see related information
Date Initiated by Firm September 04, 2014
Date Posted September 18, 2014
Recall Status1 Terminated 3 on February 22, 2017
Recall Number Z-2661-2014
Recall Event ID 69182
Product Classification Catheter, urological - Product Code KOD
Product Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile.

These catheters are indicated for the routine drainage of urine from the bladder. These catheters are not intended or designed for indwelling use.
Code Information Product Code #402100060, Lot #13491 & 13501; Product Code #402140120, Lot #13371, 13391 & 13511; Product Code #401140140, 13501, 14091, 14141, 13271, 13461, 13481, 14061, 14081 & 14101; Product Code #402140160, Lot #13411, 13291, 13311, 13301, 13391 & 13491; Product Code #402140240, Lot #13311 & 13391; Product Code #403300100, Lot #13311, 13411, 13461, 13481, 14041, 14091 & 14131; Product Code #403340140, Lot #13291; Product Code #403900080, Lot #13371 & 13411; Product Code #403900100, Lot #13261 & 13441; Product Code #403900120, Lot #13351, 13451, 13511 & 13461 and Product Code #410200200, Lot #13411. On 1/9/2015 recall expanded to include: Product Code: 40214-000080, Lot numbers 14101 & 13301; Product Code: 402140-000140, Lot number: 14281; Product Code: 402140-0001160, Lot number: 13491; Product Code: 402140-000180, Lot number: 13391 and Product Code; 402140-000240, Lot numbers: 13391 & 14027.
Recalling Firm/
Manufacturer		 Teleflex Medical
2917 Weck Dr
Research Triangle Park NC 27709-0186
For Additional Information Contact Michael T. Taggart
919-433-4940
Manufacturer Reason
for Recall		 Misbranding: Although the product labeling identifies the catheters as "soft rubber," the Natural Rubber Latex caution statement was not printed on the product label.
FDA Determined
Cause 2		 Labeling Change Control
Action Consignees were notified via letter on/about 09/04/2014. Subsequently, consignees were notified of the expanded recall on 01/13/2015.
Quantity in Commerce 193,363 ea. + 1,140 units (total 194,503 units)
Distribution Worldwide Distribution-USA (nationwide) and the countries of Austria, Belgium, Bahrain, Belgrad, Canada, Croatia, Cypress, Czeck Republic, Denmark, Finland, Germany, Great Britain, Hungary, Ireland, Italy, Libya, Netherlands, Norway, Romania, Russia, Saudi Arabia, Slavonia, Slovakia, Spain, Switzerland, Turkey, Portugal and Zambia.
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.
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