Recalls / —

—#169597

Product

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

FDA product code

FOZ — Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K990236

Affected lot / code info

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

Why it was recalled

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

Root cause (FDA determination)

Equipment maintenance

Action the firm took

On about November 26, 2018, Smiths Medical sent an URGENT MEDICAL DEVICE RECALL NOTICE via email or FedEx, (where email addresses are not available) and accompanying Recall Response Forms to all consignees who purchased potentially affected product. Consignees with potentially affected product were instructed to immediately segregate the product and return them to Stericycle, via pre-paid shipping label. They we also instructed to notify customers if the affected product was further distributed and complete and return the Recall Response Form. Questions can be submitted to Smith Medical via email at fieldactions@smiths-medical.com.

Recalling firm

Firm

Smiths Medical ASD Inc.

Address

6000 Nathan Ln N, Minneapolis, Minnesota 55442-1690

Distribution

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

Timeline

Recall initiated

2018-11-26

Terminated

2021-05-13

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #169597. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.