RegWardenFDA facility compliance records
Facility

MEDICAL COMPONENTS INC

17 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2012: 2 recalls; 2014: 1 recalls; 2015: 3 recalls; 2016: 1 recalls; 2017: 3 recalls, 1 inspections; 2018: 3 recalls; 2019: 2 recalls; 2020: 1 recalls; 2021: 1 recalls, 1 inspections2’12’131’143’151’164’173’182’191’202’21’22’23’24’25’26
  • Recalls (17)
  • Inspections (2)

Devices registered here (1)

Recalls & enforcement

20211 record
  • Class IIOngoing2021-01-13
    The 5F Dignity CT Port kits were packaged with the incorrect size port. The kits include a 6.6F port instead of the correct 5F port. The inability to connect the catheter lumen to the port stem because of the incorrect size may not be noted until well into the procedure, after th…
20201 record
  • Class IITerminated2020-07-27
    Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
20192 records
  • Class IITerminated2019-03-13
    Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
  • Class IITerminated2019-03-13
    Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
20183 records
  • Class IITerminated2018-10-01
    When the iPad is updated with Apple iOS software version 12, the C3 application malfunctions. Upon launching a new procedure, the ECG waves do not appear on the screen, in surface or internal mode. If the C3 application is not operating properly, the PICC procedure must be comp…
  • Class IITerminated2018-07-12
    The suture wings have the potential to crack or break. Potential patient injury includes catheter dislocation, bleeding, and air emboli. The firm has received six complaints (29 broken suture wings) to date for malfunction, without serious injury or death.
  • Class IITerminated2018-02-23
    There is the potential for connection failures related to the female two-part luer to hemodialysis blood tubing lines, etc. which may contribute to blood loss or air emboli.
20173 records
  • Class IITerminated2017-11-22
    The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
  • Class IITerminated2017-05-25
    The kit was packaged with the incorrect introducer needle size. The label indicates the kit contains an 18G Needle w/Echo Tip. The kits were packaged with a 21G Needle w/Echo Tip.
  • Class IITerminated2017-02-23
    The 9.6F port kits were packaged with the incorrect valved peelable introducer. The label states the kit contains a 10F valved peelable introducer. The kit is packaged with a 9F valved peelable introducer. The port lumen will not fit through the introducer during the insertion pr…
20161 record
20153 records
  • Class IITerminated2015-02-05
    Medcomp has initiated the recall of Duo-Flow 400XL Catheter, Hemo-Flow Catheter, SLX Catheter, Triple Lumen Infusion Catheter, CT rated PICC, Split Cath III, PC Split Cath III because the product shipped was out of specification. One BI (biological indicator) out of 21 on the ste…
  • Class IITerminated2015-01-28
    The dual port with catheters was not covered under FDA clearance.
  • Class IITerminated2015-01-21
    Drug products contained within the kits may have been rendered ineffective by a duplicate sterilization process. The kits include one or more of the following drugs: 5ml ampule of lidocaine, 3ml Chloraprep one-step, 10ml pre-filled saline syringe, Hygea saline wipes, and…
20141 record
20122 records
  • Class IITerminated2012-12-13
    The affected product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.
  • Class IITerminated2012-04-02
    Product was packaged with the incorrect port and does not match the label. The kit is labeled as an 8F Low Profile Pro-Fuse CT Port. The kit contains an 8F Midsize Dignity CT Port.

FDA inspections (2)

  • NAI2021-09-23
    No Action Indicated · Compliance: Devices
  • VAI2017-06-14
    Voluntary Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MEDICAL COMPONENTS INC (FEI 2518902) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/2518902-medical-components-inc/

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