||December 17, 2013
|Recall Event ID
||Nephros Dual Stage Ultra Filter (DSU) Brochure
Revisions: 0, 1, 2
Product Usage: A disposable point of use water ultrafilter that delivers microbiologically pure water for washing and drinking.
||Item #70-0230; 70-0231; 70-0232; 70-0234; and 70-0235
Document numbers 60-0237 (all) and 60-3003 (all)
41 Grand Ave
|For Additional Information Contact
||Ms. Eileen Sukumaran
|Promotional materials for non-medical water filtration products were determined to promote claims which constitute marketing the product as a medical device.
|Labeling False and Misleading
||Nephros Inc., sent an Urgent Medical Device Recall letter dated October 29, 2013 to all affected customers via UPS 2nd Day Air. The letter identified the affected product, problem and actions to be taken. Customer are asked to provide a customer information list, immediately remove and discard all affected product labeling materials and any independent labeling materials they have created for the affected products. Customers are instructed to complete and sign the attached Response Form to acknowledge receipt, understanding and compliance with the instruction. For questions contact the Nephros representative at 201-343-5202 x 100.
The letter was also posted at : http://www.nephros.com/download/news/DSU_Recall_Letters.pdf
|Quantity in Commerce
||3,367 untis with affected labeling
||USA Nationwide Distribution
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.