RecallRadar

FDA Device recall Z-0352-2020

ProtectIV¿ Plus Safety IV Catheter, sterile

On 2019-11-20 the FDA classified a Class II recall of ProtectIV¿ Plus Safety IV Catheter, sterile by Smiths Medical Asd, citing certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-0352-2020
ClassificationClass II
Statusterminated
Initiated2018-11-26
Published2019-11-20
Last updated2026-09-13 11:55 UTC
CompanySmiths Medical Asd
DistributionAK, AZ, FL, GA, IL, IN, KS, LA, MD, MN, MS, NC, NJ, NY, OH, PA, SC, TN, TX, VA, WA

Product

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

Reason

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

Identifiers

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

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0352-2020%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.