Tearaway Introducer, Model # VS203, VS303, 510 K # 130687… recallZ-1924-2016 · Medical Components, Inc dba MedComp · initiated May 5, 2016
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medical Components, Inc dba MedComp or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
This recall has been initiated due to the product labeled with the incorrect expiration date.
FDA root cause category: Labeling mix-ups
What the company is doing
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.
Recall details
- Recall number
- Z-1924-2016
- Status
- Terminated
- Initiated by the company
- May 5, 2016
- Posted by the FDA
- Jun 7, 2016
- Recalling firm
- Medical Components, Inc dba MedComp
- Quantity
- VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
- Product code
- DYB
- FDA submissions
- K130687
- Distribution
- US Distributed to: FL, TX, NC
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
2 devices in the FDA device registry whose identifier appears in the recall's code information.
- VASCU-SHEATH TEARAWAY INTRODUCERVASCU-SHEATH TEARAWAY INTRODUCER VS203Medical Components, Inc. · INTRODUCER, CATHETER1 recall0 reports
- VASCU-SHEATH TEARAWAY INTRODUCERVASCU-SHEATH TEARAWAY INTRODUCER VS303Medical Components, Inc. · INTRODUCER, CATHETER1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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