Z-1485-2017 Class II Terminated
FDA device recall Z-1485-2017 was initiated by Purewick Corporation on February 24, 2016 and is designated Class II. Reason for recall: 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 recall status is terminated (terminated May 9, 2017). Affected quantity: 176,863 units.
Recall Details
- Product Type
- Devices
- Report Date
- March 29, 2017
- Initiation Date
- February 24, 2016
- Termination Date
- May 9, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 176,863 units
Product Description
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 never a reversal of flow direction or static state of fluid between the device and the patient. Also, the dry natural rubber component is double wrapped with 75D polyester and it is not stretched in its application to expose bare rubber to a user. The Wick does not enter the vagina (Figure 1).
Reason for Recall
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.
Distribution Pattern
US: Nationwide Distribution
Code Information
Item # 625