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U.S. Department of Health and Human Services

Class 2 Device Recall Tearaway Introducer

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 Class 2 Device Recall Tearaway Introducersee related information
Date Initiated by FirmMay 05, 2016
Date PostedJune 07, 2016
Recall Status1 Terminated 3 on June 16, 2017
Recall NumberZ-1924-2016
Recall Event ID 74176
510(K)NumberK130687 
Product Classification Introducer, catheter - Product Code DYB
ProductTearaway 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.
Code Information 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
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438-2936
For Additional Information ContactSusan M. Smith
215-256-4201
Manufacturer Reason
for Recall		This recall has been initiated due to the product labeled with the incorrect expiration date.
FDA Determined
Cause 2		Labeling mix-ups
ActionMedComp 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 in CommerceVS203 Lot# MBZX140 (100 units); VS303 Lot # MBZL450 (60 units); VS303 Lot # MBZV930 (65 units); VS303 Lot # MBZZ490 (33 units).
DistributionUS Distributed to: FL, TX, NC
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = DYB
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