Z-1924-2016Class II

Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per...

Name: Z-1924-2016 Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per...
Creator: Medical Components, Inc dba MedComp
Published: 2016-05-05
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2016-05-05 / Terminated / root cause: labeling and UDI

FDA source

Medical Components, Inc dba MedComp began a recall of Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot # MBZ140, MBZL450, MBZV930 MBZZ490... on 2016-05-05. FDA classified it as Class II and gives the reason as "This recall has been initiated due to the product labeled with the incorrect expiration date". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1924-2016
Classification: Class II
Status: Terminated
Initiated: 2016-05-05
Posted: 2016-06-07
Terminated: 2017-06-16
Recalling firm: Medical Components, Inc.
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.
Product code: DYB Introducer, Catheter
Reason for recall: This recall has been initiated due to the product labeled with the incorrect expiration date.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: MedComp sent a Product Recall letter dated May 5, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to evaluate their inventory and quarantine for the return of all un-used affected product. They were asked to contact Customer Service for a Return Goods Authorization (RGA) number at 215-256-9191.
Quantity in commerce: VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
Distribution: US Distributed to: FL, TX, NC
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1924-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1924-2016	Class II	Terminated	Voluntary: Firm initiated	2016-06-15	2016-06-07

Product code DYB

K130687Class II2F & 3F Vascu-Sheath Tearaway IntroducerMedical Components, Inc. / cleared 2013-08-15

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)