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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Medical Components, Inc dba MedComp
- Category
- Medical Device — Vascular Access
- Hazard
Distribution
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