Recall Z-1924-2016 ยท DYB Introducer, Catheter
Medical Components, Inc dba MedComp
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.
| Date | Jun 7, 2016 (initiated May 5, 2016) |
| Status | Terminated |
| Reason | This recall has been initiated due to the product labeled with the incorrect expiration date. |
| Root cause | Labeling mix-ups |
| 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. |
| Quantity | VS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 |
| Distribution | US Distributed to: FL, TX, NC |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130687 | 2F & 3F VASCU-SHEATH TEARAWAY INTRODUCER Medical Components, Inc., Aug 15, 2013 |