Z-2216-2019Class II

14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424

Name: Z-2216-2019 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424
Creator: Medical Components, Inc dba MedComp
Published: 2019-03-13
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2019-03-13 / Terminated / root cause: labeling and UDI

FDA source

Medical Components, Inc dba MedComp began a recall of 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter on 2019-03-13. FDA classified it as Class II and gives the reason as "Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2216-2019
Classification: Class II
Status: Terminated
Initiated: 2019-03-13
Posted: 2019-08-08
Terminated: 2024-03-05
Recalling firm: Medical Components, Inc.
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
Product code: LFJ Catheter, Subclavian
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.
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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 ([email protected]). Contact Information for questions: Monday through Friday, 8:00 AM to 4:00 PM, Eastern Standard Time. Phone: 215-256-4201; Email: [email protected]
Quantity in commerce: 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.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2216-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2215-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07
Z-2216-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07
Z-2217-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-07

Product code LFJ

K893439Class IIHemo-Cath Silicone Double Lumen Cath Sl28c & Sl40cMedical Components, Inc. / cleared 1989-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)