FDAFDA · Food and drugs·Recall number Z-1335-2018
AGB+ Multi Lumen CVC Kit (1) Part Number (PN): CDC-42703-B1A, (2) PN: CDC-42802-1A, (3) CDC-45703-1A, (4) CDC-45703-A1A, (5) PN: CDC-45703-B1A; AGB+ Quad-Lumen CVC Kit (6) PN: CDC-42854-1A, (7) PN: CDC-45854-1A; AGB+ Two-Lumen CVC Kit (8) PN: CDC-45802-1A, (9) PN: CDC-45802-B1A, (10) PN: CDC-46702-1A, (11) CDC-47702-1A; (12) Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features, PN: ASK-45703-AH
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) 13F17F0049; (2) 13F17B0224, 13F17E0142, 13F17E0830; (3) 13F16L0220; (4) 13F17E0463, 13F17F0169; (5) 13F17E0685; (6) 13F17D0275, 13F17D0325; (7) 13F17C0470, 13F17D0243; (8) 13F17E0358; (9) 13F17B0031, 13F17E0626; (10) 13F17B0035, 13F17E0627; (11) 13F17B0135, 13F17D0191; (12) 13F16M0173, 13F17C0414
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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