Z-0352-2020 Class II Terminated
FDA device recall Z-0352-2020 was initiated by Smiths Medical ASD Inc. on Nov 26, 2018 and is designated Class II. Reason for recall: Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard. The recall status is terminated (terminated May 13, 2021). Affected quantity: 219,150 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2019
- Initiation Date
- Nov 26, 2018
- Termination Date
- May 13, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 219,150 devices
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.
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
Code Information
Model number 306701; Lot numbers: 3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, 3651082.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0352-2020
- openFDA file date
- Oct 21, 2026
- Loaded by RegDataLab
- Oct 23, 2026