FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
- Recall number
- Z-2940-2020
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
- Status
- Terminated
- Initiated
- 2020-07-27
- Posted
- not on file
- Terminated
- 2021-04-30
- Reason
- 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
- 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 (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.
- Quantity
- 132 eaches
- Distribution
- AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA
- Lot, serial or model codes
- Lot # MPCT670, UDI 884908129304 Exp. Date 12/20/2020
- 510(k) numbers
- ["K994105"]
- PMA numbers
- not on file
- Product code
- MSD
- Firm FEI
- 2518902
- Firm city
- Harleysville
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28