Z-0352-2020Class II

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

Name: Z-0352-2020 ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton
Creator: Smiths Medical ASD Inc.
Published: 2018-11-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2018-11-26 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD Inc. began a recall of ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton on 2018-11-26. FDA classified it as Class II and gives the reason as "Certain lots of the Model 306701 ProtectIV Plus Safety IV Catheter may exhibit damage on the safety mechanism guard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0352-2020
Classification: Class II
Status: Terminated
Initiated: 2018-11-26
Posted: 2019-11-08
Terminated: 2021-05-13
Recalling firm: Abbott Medical
Product: ProtectIV Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Certain lots of the Model 306701 ProtectIV Plus Safety IV Catheter may exhibit damage on the safety mechanism guard.
Root cause tag: manufacturing process
FDA 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 [email protected].
Quantity in commerce: 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
Product codes and lots: Model number 306701; Lot numbers: 3635765, 3639446, 3642834, 3646828, 3646829, 3646830, 3646831, 3646832, 3646833, 3651082.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0352-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0352-2020	Class II	Terminated	Voluntary: Firm initiated	2019-11-20	2019-11-08

Product code FOZ

K990236Class IIModification of Jelco*,jelco*-W and Jelco* Plus i.v. Catheters, Cathlon* i.v. Catheters, Optiva* i.v. Catheters, ProtectJohnson & Johnson Medical, Div. of Ethicon, Inc. / cleared 1999-08-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)