Z-0723-2019 Class II Terminated
FDA device recall Z-0723-2019 was initiated by Arrow International Inc on Nov 14, 2018 and is designated Class II. Reason for recall: The lidstock states the incorrect priming volume and flow rates. The recall status is terminated (terminated Jun 4, 2020). Affected quantity: 15 in the US.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 23, 2019
- Initiation Date
- Nov 14, 2018
- Termination Date
- Jun 4, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 in the US
Product Description
Arrow CVC 2 Lumen, Pediatric Two-Lumen Central Venous Cauterization Set with Blue FlexTip Catheter, 4 Fr 2 Lumen 5cm, Reference # CS-12402 The Arrow CVC is intended to provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access, including, but not limited to the following: " Lack of usable peripheral IV sites " Central venous pressure monitoring " Total parenteral nutrition (TPN) " Infusions of fluids, medications, or chemotherapy " Frequent blood sampling or receiving blood transfusions/blood products
Reason for Recall
The lidstock states the incorrect priming volume and flow rates.
Distribution Pattern
Worldwide distribution: US (nationwide) distribution to state of: FL and to countries of: Argentina, Canada, Chile, Columbia, Costa Rica, Dominican Republic, Ecuador, and Peru.
Code Information
Lots 14F18F0336 & 14F18E0121
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0723-2019
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026