(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
Reported: April 18, 2018 Initiated: December 22, 2017 #Z-1332-2018
Product Description
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A
Reason for Recall
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Details
- Recalling Firm
- Arrow International Inc
- Distribution
- Distributed in all 50 U.S. states and the District of Columbia. Distributed in Bahamas, Canada, Mexico, Panama, and Singapore.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
(1) Access Tray, Part Number (PN): ASK-04001-MS; Arrow Multi-Lumen CVC Kit (2) PN: CDC-12703-1A; (3) PN: CDC-15703-1A; (4) PN: CDC-15703-B1A; Arrow Two-Lumen CVC Kit (5) PN: CDC-12802-1A; (6) PN: CDC-15802-1A; (7) PN: CDC-17702-1A. Recalled by Arrow International Inc.
Why was this product recalled? ▼
Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 18, 2018. Severity: Moderate. Recall number: Z-1332-2018.
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