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

FDA Recall #Z-0352-2020 — Class II — November 26, 2018

Recall #Z-0352-2020 Date: November 26, 2018 Classification: Class II Status: Terminated

Product Description

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.

Recalling Firm

Smiths Medical ASD Inc. — Minneapolis, MN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

219,150 devices

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

Code Information

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

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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