FDA recall Z-0352-2020

Smiths Medical ASD Inc. · Class II · device

Product

ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.

Reason for recall

Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.

Distribution

United States - AK, AZ, FL, GA, IL, IN, KS, LA, MD, MN, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA. One foeign consignee in Costa Rica

Key facts

Status
Terminated
Initiation date
2018-11-26
Report date
2019-11-20
Termination date
2021-05-13
Voluntary/Mandated
Voluntary: Firm initiated
Location
Minneapolis, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0352-2020