Recall Z-1924-2016— Medical Components, Inc dba MedComp

Name: FDA recall Z-1924-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-05

Class II · Terminated

Class II FDA medical device recall by Medical Components, Inc dba MedComp, initiated 2016-05-05, terminated 2017-06-16. It names one FDA 510(k) clearance: K130687. Product: Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.. Reason: This recall has been initiated due to the product labeled with the incorrect expiration date..

Recalling firm: Medical Components, Inc dba MedComp
Classification: Class II
Status: Terminated
Initiated: 2016-05-05
Terminated: 2017-06-16
Firm location: Harleysville, PA, United States

510(k) clearances named in this recall

1 on FDA's record

K130687 — 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCERMedical Components, Inc.·cleared 2013-08-15

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

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490 Product Usage: The 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children.

Reason for recall

This recall has been initiated due to the product labeled with the incorrect expiration date.

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