| Date Initiated by Firm | February 24, 2016 |
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| Date Posted | March 06, 2017 |
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| Recall Status1 |
Terminated 3 on May 09, 2017 |
| Recall Number | Z-1485-2017 |
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| Recall Event ID |
76571 |
| Product Classification |
Bag, urine collection, leg, for external use, non-sterile - Product Code NNW
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| Product | 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). |
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| Code Information |
Item # 625 |
Recalling Firm/
Manufacturer |
Purewick Corporation
2030 Gillespie Way Ste 109
El Cajon CA 92020-0910
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| For Additional Information Contact | Sandra Fisher
619-660-0734 |
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Manufacturer 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. |
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FDA Determined
Cause 2 | Labeling design |
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| 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 reports of adverse events related to the error in labeling. Customers are informed of the risk to health and the actions to be taken. Customers are instructed to complete the enclosed PureWick Field Correction form and fax to PureWick Corporation at (619) 660-5459 or email to response@purewick.com. Customers with questions or would like assistance completing the PureWick Field Correction Form are instructed to call PureWick toll-free at (844) 584-0734 Monday Friday from 8:00 a.m. to 4:30 p.m., Pacific Time. |
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| Quantity in Commerce | 176,863 units |
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| Distribution | US: Nationwide Distribution |
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| Total Product Life Cycle | TPLC Device Report |
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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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