Z-1106-2021 Class II Terminated
FDA device recall Z-1106-2021 was initiated by Arrow International Inc on January 6, 2021 and is designated Class II. Reason for recall: The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not ide… The recall status is terminated (terminated July 12, 2022). Affected quantity: 1,705 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- February 17, 2021
- Initiation Date
- January 6, 2021
- Termination Date
- July 12, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,705 eaches
Product Description
Arrow AGB+ Multi-Lumen CVC Kit 7Fr 3 Lumen- Intended for venous access to the central circulation by the way of the femoral, jugular, or subclavian veins. Product Code: CDC-45703-1A
Reason for Recall
The lidstock / information card on the kits correctly states the product code as CDC-45703-1A. The banner card on the side of the kit may incorrectly state the product code as CDC-15703-1A and not identify the product as a coated ARROWg+ard Blue PLUS (AGB+) antimicrobial catheter which may cause a minor delay during use and placement of a coated catheter in patients with known sensitivity to chlorohexidine, silver sulfadiazine or sulfa could result in an allergic reaction
Distribution Pattern
US Nationwide
Code Information
Lot Code: 13F20E0173