The Recall Desk
LowFDA (Devices)·Z-1924-2016·Announced 2016-06-15

MedComp Recalls Tearaway Introducers Due to Incorrect Expiration Date Labeling

Medical Components, Inc dba MedComp is recalling specific lots of Tearaway Introducers because they are labeled with incorrect expiration dates.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is due to a documentation and labeling error (incorrect expiration date) with no reported injuries or illnesses, fitting the criteria for a Low severity recall.

Plain-English summary

Medical Components, Inc dba MedComp is recalling specific lots of Tearaway Introducers, Models VS203 and VS303. The recall was initiated because the products are labeled with the incorrect expiration date.

The affected products are intended for percutaneous venous access by modified Seldinger Technique in neonates, infants, and children. The recall includes 100 units of VS203 Lot # MBZX140, 60 units of VS303 Lot # MBZL450, 65 units of VS303 Lot # MBZV930, and 33 units of VS303 Lot # MBZZ490.

These products were distributed in Florida, Texas, and North Carolina. The source text does not specify further actions for consumers or healthcare providers beyond the initiation of the recall.

The recalled product

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 Seldi

Distribution

Distributed in 3 states:

Same manufacturer · Medical Components, Inc dba MedComp

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