FDA recall Z-2790-2018

Product

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

Puerto Rico

Key facts

Status

Ongoing

Initiation date

2016-10-19

Report date

2018-08-22

Voluntary/Mandated

Voluntary: Firm initiated

Location

Guangzhou, China

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2790-2018