14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
- Recall Initiated
- March 13, 2019
- Terminated
- March 5, 2024
- Recall Number
- Z-2215-2019
- Quantity
- 6830
- Firm Location
- Harleysville, PA
Reason for Recall
Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
Distribution
US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
Lot / Code Info
MCAK580 MCAS990 MCAY850 MCBA850 MCBH150 MCBN670 MCBY930 MCCC770 MCCK640 MCCN740 MCCR330 MCCW790 MCDC600 MCDK990 MCDR410 MCFB340 MCFG840 MCFL120 MCFP220 MCFT420 MCFZ280 MKAF340 MKAG480 MKAN280 MKAT110 MKAX330 MKBA730 MKBH920 MKBN710 MKBX790 MMAB370 MMAD450 MMAQ940
Root Cause
Labeling Change Control
Action Taken
On March 13, 2019, the firm notified customers via Urgent Medical Device Recall letter. Customers were informed that the kits contain a 15F "non-valved" peelable introducer despite the label indicating that the kit is packaged with a "valved" introducer. Customers were asked to do the following: 1. Immediately examine your inventory and quarantine product subject to recall. 2. If you have further distributed this product, please identify your customers and immediately notify them of the recall. 3. Contact your Medical Components, Inc. customer service representative for a Returned Goods Authorization (RGA) number if you have product to return. The phone number to call is 215-256-4201. 4.Complete and return the Medical Device Recall Return Response Form. The form can be returned by fax (215-256-9191) or email (recalls@medcompnet.com). Contact Information for questions: Monday through Friday, 8:00 AM to 4:00 PM, Eastern Standard Time. Phone: 215-256-4201; Email: recalls@medcompnet.com