FDA Medical Device Recalls (openFDA)
Medical Components, Inc dba MedComp: Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits.
- Recall number
- Z-0161-2010
- Recalling firm
- Medical Components, Inc dba MedComp
- Product
- Medcomp, 10F Bioflex Tesio Kit with cutting trocar. Catalog number BFR-6CTT 5 per box. Hemodialysis catheter insertion kits.
- Status
- Terminated
- Initiated
- 2009-09-02
- Posted
- 2009-11-10
- Terminated
- 2010-04-16
- Reason
- mislabeled as right are actually left
- Root cause
- Employee error
- Action
- Medcomp issued a "Product Alert" letter dated September 2, 2009 to all customers informing them of the problem and the need to return the product. For further information, contact Medcomp at 215-256-4201.
- Quantity
- 100 trays
- Distribution
- Worldwide Distribution -- United States (AR, FL, KS, LA, MO, PA, TN, and TX) and Austria.
- Lot, serial or model codes
- Lot Number: MAVV890, exp 2014/07.
- 510(k) numbers
- ["K971925"]
- 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