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Terminated

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

FDA Recall Z-0352-2020 · Posted None

Recall StatusTerminated
Product CodeFOZ
Date Initiated2018-11-26
Date Terminated2021-05-13
Product Quantity219,150 devices

Reason for Recall

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

Firm Action

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 [email protected].

Root Cause

Equipment maintenance

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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