FDA recall Z-3030-2017

Product

VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.

Reason for recall

Punctures in blister packaging that was detected during the packaging process.

Distribution

Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan.

Key facts

Status

Terminated

Initiation date

2017-06-30

Report date

2017-08-23

Termination date

2021-02-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

San Diego, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3030-2017