FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
- Recall number
- Z-0352-2020
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
- Status
- Terminated
- Initiated
- 2018-11-26
- Posted
- not on file
- Terminated
- 2021-05-13
- Reason
- Certain lots of the Model 306701 ProtectIV Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
- Root cause
- Equipment maintenance
- 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 fieldactions@smiths-medical.com.
- 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
- Lot, serial or model codes
- Model number 306701; Lot numbers: 3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, 3651082.
- 510(k) numbers
- ["K990236"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28