Recall Z-1485-2017 ยท NNW Bag, Urine Collection, Leg, For External Use, Non-Sterile
Purewick Corporation
PureWick External Catheter for Women-Wick Product Usage: A flexible, contoured external catheter (a Wick) is positioned between the labia and gluteus muscles. The function of the Wick is to draw urine away from the body through the Wick to a storage container away from the body through a PVC tube via a continuous, low pressure vacuum pump (PureWick DryDoc) or to a hospital wall vacuum. There is
| Date | Mar 6, 2017 (initiated Feb 24, 2016) |
| Status | Terminated |
| Reason | PureWick is recalling external catheter for women Wicks because the labeling did not contain the phrase "This product contains dry natural rubber" and/or erroneously included the phrase "Latex-free." The white gauze component of the PureWick contains dry natural rubber. |
| Root cause | Labeling design |
| Action | A Urgent Medical Device recall letter dated March 2, 2017 will be sent to customers to inform them that PureWick Corporation is recalling specific lots of PureWick external catheter for women Wicks, Item #625. Customers are informed that PureWick is recalling PureWick Wicks because labeling on product shipped prior to February 22, 2017 either did not contain the phrase This product contains dry natural rubber and/or erroneously included the phrase Latex-free. The white gauze component of the PureWick Wick contains dry natural rubber. PureWick Corporation has received zero complaints or report |
| Quantity | 176,863 units |
| Distribution | US: Nationwide Distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.