Medcomp 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.
- Recall Initiated
- February 5, 2015
- Posted
- March 30, 2015
- Terminated
- August 6, 2015
- Recall Number
- Z-1351-2015
- Quantity
- 3152
- Firm Location
- Harleysville, PA
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.
Distribution
Worldwide Distribution.
Lot / Code Info
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
Root Cause
Process control
Action Taken
On 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.