Recall Z-2216-2019
Medical Components, Inc dba MedComp · initiated March 13, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
Codes / lots: MCAL430 MCAT000 MCBM770 MCBS380 MCCC840 MCCM930 MCCS360 MCCZ450 MCDC580 MCDN120 MCDR420 MCFB350 MCFG980 MCFM410 MCFP230 MCFT430 MCFZ290 MKAF350 MKAG490 MKAM210 MKAR120 MKBA200 MKBL090 MKBL220 MKBV580 MMAB710 MMAM070 MMAQ950
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.
FDA-determined 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
Details
- Recall number
- Z-2216-2019
- Initiated
- March 13, 2019
- Terminated
- March 5, 2024
- Product code
- LFJ – Catheter, Subclavian
- Quantity
- 6830
- Distribution
- US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
- Recalling firm
- Medical Components, Inc dba MedComp, Harleysville, PA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2215-2019 Class II | 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.…Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a… | 03/13/2019Terminated |
| Z-2217-2019 Class II | 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.…Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a… | 03/13/2019Terminated |