Smiths Medical ASD Inc.: Medical Device Recall in 2019 - (Recall #: Z-0352-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: November 26, 2018

Date Posted: November 20, 2019

Recall Number: Z-0352-2020

Event ID: 81708

Reason for Recall:

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

Status: Terminated

Product Quantity: 219,150 devices

Code Information:

Model number 306701; Lot numbers: 3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, 3651082.

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated