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Recall Observatory FDA recall evidence

Device 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.

Z-1924-2016

May 05, 2016

Class II

Product summary

Firm
Medical Components, Inc dba MedComp
Event
Event 74176
Status
Terminated
Classification
Class II
Quantity
VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
Official record key
device-enforcement:Z-1924-2016

Official wording

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

Code information: Catalog Numbers/Lot Numbers/Exp. Date/UDI Number: VS203 Lot # MBZX140 exp. date 01/18/2021 UDI# 884908105209 VS303 Lot # MBZL450 exp. date 11/14/2020 UDI# 884908105216 VS303 Lot # MBZV930 exp. date 11/01/2021 UDI# 884908105216 VS303 Lot # MBZZ490 exp. date 01/28/2021 UDI# 884908105216

Distribution pattern: US Distributed to: FL, TX, NC

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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