14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
- Recall Initiated
- March 13, 2019
- Terminated
- March 5, 2024
- Recall Number
- Z-1149-2019
- 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
Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
Lot / Code Info
MCAL680 MCBA840 MCBH140 MCBK600 MCBY920 MCCH670 MCCR320 MCCV590 MCDG930 MCDK980 MCDR400 MCFB320 MCFG490 MCFR460 MCFT410 MCFY850 MCFZ660 MKAD410 MKAN270 MKAP300 MKAT100 MKAX320 MKBA190 MKBK940 MKBL210 MKBP450 MKBV570 MMAA170 MMAD480 MMAS020
Root Cause
Finished device 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