Recall Z-3030-2017— CareFusion 303, Inc.

Name: FDA recall Z-3030-2017
Creator: U.S. Food and Drug Administration
Published: 2017-06-30

Class II · Terminated

Class II FDA medical device recall by CareFusion 303, Inc., initiated 2017-06-30, terminated 2021-02-03. It names one FDA 510(k) clearance: K945070. Product: VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.. Reason: Punctures in blister packaging that was detected during the packaging process..

Recalling firm: CareFusion 303, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Terminated: 2021-02-03
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K945070 — VERSASAE PLASTIC CANNULA- 11 GAUGEImed Corp.·cleared 1995-01-13

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

VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.

Reason for recall

Punctures in blister packaging that was detected during the packaging process.

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