Z-2790-2018 Class II Ongoing
FDA device recall Z-2790-2018 was initiated by Guangzhou Improve Medical Instruments Co., Ltd. on October 19, 2016 and is designated Class II. Reason for recall: Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip. The recall status is ongoing. Affected quantity: 700,000.
Recall Details
- Product Type
- Devices
- Report Date
- August 22, 2018
- Initiation Date
- October 19, 2016
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 700,000
Product Description
Improve Blood Collection Sets with Multiple Sample Luer Adapter - Sterile/EO Product Usage: The Blood Collection Set are single-use, sterile, winged needle bonded to a flexible tubing with luer adapter. The needle consists of (1) a winged needle, (2) a flexible tubing, (3) a luer adaptor. The products and evacuated blood collection tube/ syringe are used together for the collection of venous blood.
Reason for Recall
Complaints about the needle is not smooth, with discoloration, a kind of gel agglomeration on the needle tip.
Distribution Pattern
Puerto Rico
Code Information
Serial Number 102030132 Lots #'s: 20150210 and 20150410