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 neonat
Check against the official notice below — it lists the full affected range.
Medical Components, Inc is recalling Tearaway Introducer devices, Models VS203 and VS303, due to incorrect expiration dates printed on the product labels. The affected lots are: VS203 Lot# MBZX140 (100 units with labeled expiration date 01/18/2021), VS303 Lot# MBZL450 (60 units with labeled expiration date 11/14/2020), VS303 Lot# MBZV930 (65 units with labeled expiration date 11/01/2021), and VS303 Lot# MBZZ490 (33 units with labeled expiration date 01/28/2021). These products were distributed in Florida, Texas, and North Carolina.
The recall record does not specify a remedy or recommended action for consumers who may have received these products.
Written by software from the official notice below. Not reviewed by a lawyer.
This recall has been initiated due to the product labeled with the incorrect expiration date.
Reason for recall: This recall has been initiated due to the product labeled with the incorrect expiration date. Distribution: US Distributed to: FL, TX, NC Quantity: VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units). Lot/code info: 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
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.