Smiths Medical ProtectIV Plus Safety IV Catheter Recall: Safety Mechanism Damage Risk
Smiths Medical recalls Model 306701 ProtectIV Plus Safety IV Catheter due to potential safety mechanism damage. Affected lots include 3635765-3651082. Consumers should check their catheter packaging for lot numbers.
Lower-risk recall
Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
Contact the company
What happened, in plain English
Smiths Medical is recalling certain lots of the ProtectIV Plus Safety IV Catheter (Model 306701) because the safety mechanism guard may be damaged. This could lead to the catheter not functioning properly during use, potentially causing injury. Read more at govinfonow.com/recall/69436-smiths-medical-protectiv-plus-safety-iv-catheter-recall-safety-mechanism.
Source Summary by GovInfoNow · govinfonow.com/recall/69436-smiths-medical-protectiv-plus-safety-iv-catheter-recall-safety-mechanism · Updated August 20, 2026 · FDA enforcement record: FDA #Z-0352-2020
Cite this page
“Smiths Medical ProtectIV Plus Safety IV Catheter Recall: Safety Mechanism Damage Risk.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/69436-smiths-medical-protectiv-plus-safety-iv-catheter-recall-safety-mechanism. Based on FDA recall #Z-0352-2020 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0352-2020%22&limit=1).
Why it’s dangerous
The safety mechanism guard on certain lots may be damaged, which could prevent the catheter from properly securing the needle. This might cause the catheter to become dislodged during use, increasing the risk of injury.
Who’s affected
Healthcare professionals and patients using the ProtectIV Plus Safety IV Catheter (Model 306701) are affected. Those with the specific lot numbers listed are most at risk.
How to tell if you have this one
Check the catheter packaging for the lot number: 3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, or 3651082. The product is packaged in a pouch and then an inner carton.
- Brand
Smiths Medical- Category
Medical device
What to do — step by step
Check Lot Number
Look for the lot number on the catheter packaging to determine if it's affected (3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, or 3651082).
Where it went and when
Where it was distributed
Distributed in 21 states.
FDA 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” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Alaska, Arizona, Florida, Georgia, Illinois, Indiana, Kansas, Louisiana, Maryland, Minnesota, Mississippi, New Jersey, New York, North Carolina, Ohio, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-0352-2020 (November 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0352-2020 to see it in context.
- Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.