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
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.