Reported Jun 15, 2016 · Terminated
Tearaway Introducer, Model # VS203, VS303, 510 K # 130687, packaged individually in a pouch, 5 pouches per carton, lot…
Medical Components, Inc. dba MedComp
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medical Components, Inc dba MedComp · 1499 Delp Dr · Harleysville, PA · 19438-2936
Is this the product you have?
Tearaway IntroducerModel # VS203VS303510 K # 130687packaged individually in a pouch5 pouches per cartonlot # MBZ140MBZL450
- MBZV930 MBZZ490 Product UsageThe 2F and 3F Vascu-Sheath Tearaway Introducer is intended for percutaneous venous access by modified Seldinger Technique in neonates, infants and children
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 884908105209Lot # MBZX140 exp. date 01/18/2021 UDI# 884908105209 VS303 2 884908105216Lot # MBZL450 exp. date 11/14/2020 UDI# 884908105216 VS303 3 884908105216Lot # MBZV930 exp. date 11/01/2021 UDI# 884908105216 VS303 4 884908105216Lot # MBZZ490 exp. date 01/28/2021 UDI# 884908105216 - Amount recalled
- VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
Where it was sold
Why it was recalled
This recall has been initiated due to the product labeled with the incorrect expiration date.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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