FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit
- Recall number
- Z-2693-2011
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- THD155428- 15.5F X 28cm Titan HD(TM) Catheter Kit Product Usage: Hemodialysis catheter insertion kit
- Status
- Terminated
- Initiated
- 2011-05-19
- Posted
- 2011-06-28
- Terminated
- 2016-10-24
- Reason
- Product was packaged with the incorrect valved peelable introducer. The catheter sized is 15.5F and the introducer packaged in the kit is a 15F. The kit should contain a 16F introducer.
- Root cause
- Mixed-up of materials/components
- Action
- Medcomp sent a "PRODUCT ALERT" letter dated May 19, 2011 to all affected customers. The letter described the product, problem, and actions to be taken. The letter is requesting the return of all affected product. Customers are instructed to contact their customer service representative for an RGA (returned good authorization) number. If you have any questions or concerns contact Medcomp at 215-256-4201 ext. 2225.
- Quantity
- 90
- Distribution
- Worldwide Distribution -- USA (nationwide) including states of AZ, CA, CO and RI and countries of Australia, Brazil, and Netherlands
- Lot, serial or model codes
- Lot # MAZX990; Catalog # THD155428, Exp Date 2013/03
- 510(k) numbers
- ["K030502"]
- 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