Z-2940-2020Class II

Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024

Name: Z-2940-2020 Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Creator: Medical Components, Inc dba MedComp
Published: 2020-07-27
License: https://open.fda.gov/license/

Medical Components, Inc. / initiated 2020-07-27 / Terminated / root cause: packaging

FDA source

Medical Components, Inc dba MedComp began a recall of Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024 on 2020-07-27. FDA classified it as Class II and gives the reason as "Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2940-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-27
Posted: 2020-09-06
Terminated: 2021-04-30
Recalling firm: Medical Components, Inc.
Product: Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Product code: MSD Catheter, Hemodialysis, Implanted
Reason for recall: Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: Medcomp issued Urgent Medical Device Recall letter issued first class mail to the customers on July 27, 2020. Letter states reason for recall, health risk and action to take: " Immediately examine your inventory and quarantine all product subject to recall. " Options for disposition of affected product: o Return the product to Medcomp - Contact your Medical Components, Inc. customer service representative for a Returned Goods Authorization {RGA) number. The phone number to call is 215-256-4201. o Have individually packaged and sterilized 16F peelable introducers (MR191603) sent to use with the kits. Call your customer service representative and provide the number of kits you need the replacements introducers for. Same number as above. " Complete and return the Medical Device Recall Product Disposition 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: 132 eaches
Distribution: AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA
Product codes and lots: Lot # MPCT670, UDI 884908129304 Exp. Date 12/20/2020

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2940-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2940-2020	Class II	Terminated	Voluntary: Firm initiated	2020-09-16	2020-09-06

Product code MSD

K994105Class IIHemo-Flow Double Lumen Catheter, Models Hfs-24, Hfs-28, Hfs-32, Hfs-36, Hfs-40Medical Components, Inc. / cleared 2001-10-03

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)