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.
FDA Recall Z-1924-2016 · Posted 2016-06-07
Recalling FirmMedical Components, Inc dba MedComp
Recall StatusTerminated
Product CodeDYB
Date Initiated2016-05-05
Date Terminated2017-06-16
Product QuantityVS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
Reason for Recall
This recall has been initiated due to the product labeled with the incorrect expiration date.
Firm Action
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.
Root Cause
Labeling mix-ups
Distribution Pattern
US Distributed to: FL, TX, NC
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.