Recall Z-0352-2020— Smiths Medical ASD Inc.

Name: FDA recall Z-0352-2020
Creator: U.S. Food and Drug Administration
Published: 2018-11-26

Class II · Terminated

Class II FDA medical device recall by Smiths Medical ASD Inc., initiated 2018-11-26, terminated 2021-05-13. It names one FDA 510(k) clearance: K990236. Product: ProtectIV¿ Plus Safety IV Catheter, sterile. Packaged in a pouch and than into an inner carton.. Reason: Certain lots of the Model 306701 ProtectIV¿ Plus Safety IV Catheter may exhibit damage on the safety mechanism guard..

Recalling firm: Smiths Medical ASD Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-11-26
Terminated: 2021-05-13
Firm location: Minneapolis, MN, United States

510(k) clearances named in this recall

1 on FDA's record

K990236 — MODIFICATION 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

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.