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U.S. Department of Health and Human Services

Class 2 Device Recall Various catheters marketed by Medcomp and AngioDynamics

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 Class 2 Device Recall Various catheters marketed by Medcomp and AngioDynamicssee related information
Date Initiated by FirmFebruary 05, 2015
Date PostedMarch 30, 2015
Recall Status1 Terminated 3 on August 06, 2015
Recall NumberZ-1351-2015
Recall Event ID 70472
510(K)NumberK030502 K111651 K994105 
Product Classification Catheter, hemodialysis, implanted - Product Code MSD
ProductMedcomp Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III; AngioDynamics product- Dura-Flow Catheter, Schon XL Catheter; The affected product are insertion kits used to implant the devices packaged-long and short term hemodialysis catheters and infusion catheters.
Code Information Medcomp products:Catalog Code/ Lot Number/Expiration Date: DFXL148MTE/ MGMC610/10/31/2019; HFS 32/ MGMB440/ 07/14/2017;  HFS24E./MGLY830/07/31/2017; MC061402/MGMD190/07/15/2017;  MC3L-8S/MGMD920/10/16/2019; MR17035211/MGMD680/10/31/2017;  TRAY #593-3/MGMB460/07/15/2017; RMS23602/MBWM930/07/31/2017;  ASPC2816-3/MBWM900/07/31/2017; Tray #55216-3/MBWL780/07/31/2017; ASPC2816-3PC/MBWX290/07/31/2017; 10301207/MGMD930/07/31/2017; 10800701/ MGLY730/ 07/31/2017; 10800702/ MGMD210/ 07/31/2017; 10800703/MGLY740/07/31/2017   AngioDynamics products- model numbers/lot numbers/ expiration dates:  10301207/MGMD930/07/31/2017; 10800701/MGLY730/07/31/2017; 10800702/MGMD210/07/31/2017; 10800703/MGLY740/07/31/2017  
Recalling Firm/
Manufacturer		 Medical Components, Inc dba MedComp
1499 Delp Dr
Harleysville PA 19438
For Additional Information ContactCustomer Support
215-256-4201
Manufacturer Reason
for Recall		Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the sterilization load was out of specification.
FDA Determined
Cause 2		Process control
ActionOn or about 02/03/2015, Medcomp sales representatives notified the affected medical facilities and providing Medcomp's recall letter. This was accomplished by e-mail, telephone, or visit. Distributors for the international accounts were notified by Medcomp via e-mail. A copy of Medcomp's recall letter was attached. For AngioDynamics product- Medcomp notified AngioDynamics by e-mail of the product recall. Every consignee was requested to complete and return Page 2 of the recall letter verifying receipt of the recall and disposition of the product they received. AngioDynamics was requested to provide an account of the disposition for the total number of product they received.
Quantity in Commerce3152
DistributionWorldwide Distribution.
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 = MSD
510(K)s with Product Code = MSD
510(K)s with Product Code = MSD
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