FDAFDA · Food and drugs·Recall number Z-1331-2018
(1) Central Venous Catheterization Kit, Part Number (PN): ASK-04300-PHP; (2) Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, PN: ASK-04301-WBH; (3) Vessel Catheterization Kit, PN: ASK-04550-NYP
Published April 18, 2018 · Recall initiated: December 22, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Arrow International Inc
- Distributor
- Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
- Lot
- Lot Numbers: (1) 13F17D0048; (2) 13F17E0659; (3) 13F17A0075, 13F17C0503, 13F17D0296, 13F17E0541, 13F17F0220, 13F17G0002
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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