Harleysville, PA, United States
Medical Components, Inc dba MedComp recalls
9 recalls recorded since 2018, most recently on 13 January 2021. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls9
Ongoing (FDA)1
Terminated or completed8
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 13 January 2021
- Reason
- 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 the catheter lumen is placed in the vessel. An alternate port will need to be obtained prolonging the procedure. A prolonged insertion procedure increases any risk associated with a surgical procedure.
- Distribution
- US Nationwide distribution in the states of CA, DC, GA, IL, IN, MA, MI, NJ, NM, NY, OH, PA, TX. Updated 3/11/2021
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1184-2021
- Power Injectable CT Port insertion kits - Product Usage: is an implantable access device designed to provide repeated access to the vascular system.
Terminated Class II Medical devices
- Recall started
- 27 July 2020
- Terminated
- 30 April 2021
- Reason
- Kits were packaged with the incorrect size valve peelable introducer. The kits include a 15F instead of the correct 16F valve peelable introducer
- Distribution
- AZ, CA. FL. GA, NC, ND, NJ, NY, OH, PA, VA, WA
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2940-2020
- Medcomp 15.SF X 24CM Titan HD CATHETER (CUFF 19CM FROM TIP) Ref: THD155024
Terminated Class II Medical devices
- Recall started
- 13 March 2019
- Terminated
- 5 March 2024
- Reason
- Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
- Distribution
- Distributed to accounts in CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1149-2019
- 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422
Terminated Class II Medical devices
- Recall started
- 13 March 2019
- Terminated
- 5 March 2024
- Reason
- Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits contain a 15F "non-valved" peelable introducer.
- Distribution
- US Nationwide Distribution CA FL GA IN KY LA MA MI MO MS NJ NY OH OK PA SC TN TX VA WV.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2216-2019, Z-2215-2019, Z-2217-2019
- 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424 Product Usage: An aid for introducing a hemodialysis catheter
- 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423 Product Usage: An aid for introducing a hemodialysis catheter
- 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425 Product Usage: An aid for introducing a hemodialysis catheter
Terminated Class II Medical devices
- Recall started
- 1 October 2018
- Terminated
- 1 October 2020
- Reason
- 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 completed without using alternate methods to confirm PICC tip placement.
- Distribution
- Distributed to accounts in AZ, CA, CO, FL, IL, LA, MA, ME, NC, OH, TN, VA, and WV. Foreign distribution to Canada, Croatia, Czech Republic, Great Britain, Greece, Italy, Netherlands, Slovenia, and Sweden.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0222-2020
Terminated Class II Medical devices
- Recall started
- 12 July 2018
- Terminated
- 2 July 2020
- Reason
- 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.
- Distribution
- Nationwide distribution; worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2940-2018, Z-2932-2018, Z-2936-2018, Z-2938-2018, Z-2939-2018, Z-2933-2018, Z-2935-2018, Z-2942-2018, Z-2937-2018, Z-2941-2018, Z-2934-2018
- SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER/CATHETER SET; T94C T94M T96M T98M
- Duo-Flow XTP Straight Full Set; Hemodialysis catheter insertion kits, AAC02106 AAC02107 AAC02108
- Duo-Flow Catheter Full Tray; MCDLT3500 MCDLT4000 MCDLT4400 MCDLT4424# Hemodialysis catheter insertion kits
- Duo-Flow Double Lumen Catheter Only/Catheter Set; T114C T114M T116C T116M T116ME T118C T118M T118ME T119M
- SOFT-LINE DUO-FLOW DOUBLE LUMEN CATHETER TRAY; T3500 T4000 T4400 T4424
- Double Lumen CRRT/ABP Catheter Set; Hemodialysis catheter insertion kits, DL 11/15 DL 11/20 DL 9/15
- Duo-Flow IJ Full Tray; MCDLT114IJ MCDLT116IJ MCDLT118IJ
- DUO FLOW DOUBLE LUMEN CATHETER, XTP114CT, XTP114MT, ; RAULERSON DUO FLOW IJ DOUBLE LUMEN CATHETER/CATHETER SET, XTP114IJC, XTP114IJS, XTP114IJSE, XTP114MT-C, XTP116IJC, XTP116IJS, XTP116IJSE RAULERSON PRE-CURVED DUO-FL
- and 3 more product lines
Terminated Class II Medical devices
- Recall started
- 23 February 2018
- Terminated
- 10 January 2020
- Reason
- 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.
- Distribution
- Worldwide Distribution - US Nationwide in the states of AL, AR, CA, CO, CT, DE, FL, GA, IL, IN, KS, LA, MA, MD, MI, MN, MS, NC, NH, NJ, NM, NV, NY, OH, OK, PA, RI, TN, TX, UT, VA, VT, WA & WI. International: Australia, Austria, Belgium, Canada, Ecuador, France, Germany, Great Britain Greece, Ir
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1124-2018, Z-1120-2018, Z-1121-2018, Z-1122-2018, Z-1127-2018, Z-1126-2018, Z-1125-2018, Z-1118-2018, Z-1119-2018, Z-1123-2018
- 12F Tesio CATHETER SET (CUFF 32CM FROM TIP), REF MCTC1247SD, UDI 884908027266 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions whe
- 12F X 40CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD755, UDI 884908005530 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions wher
- 12F X 60CM TESIO CATHETER SET WITH "Y" ADAPTOR, REF CMD757, UDI 884908005554 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions wher
- 12F Tesio CATHETER SET (CUFF 22CM FROM TIP), REF MCTC1235SD, UDI 884908027242 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions whe
- REPAIR KIT, REF RPK-01, UDI 884908039856 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5cm viable
- CATHETER REPAIR KIT, REF RMS52001, UDI 884908039658 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4
- TWO PART ADAPTER, REF MCTLA2000, UDI 884908027310 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of 4.5
- CATHETER REPAIR KIT, REF AAC52001, UDI 884908001891 Product Usage: The Medcomp Repair Kit is indicated for use in replacing damaged female her connectors, clamps, or repairing extensions where there is a minimum of
- and 2 more product lines
Terminated Class II Medical devices
- Recall started
- 22 November 2017
- Terminated
- 11 July 2018
- Reason
- 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.
- Distribution
- CA, AR. AL
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1271-2018
- 8F Plastic Dignity¿ Low Profile CT Port W/Pre-Attached ChronoFlex¿ Polyurethane Catheter
Terminated Class II Medical devices
- Recall started
- 25 May 2017
- Terminated
- 4 September 2018
- Reason
- 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.
- Distribution
- Arabia, Australia, Israel, Brunei & Jamaica
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0533-2018
- 6.6F Plastic Dignity¿ Low Profile CT Port W/Attachable ChronoFlex¿ Polyurethane Catheter, Catalog # MRCTI66041, UDI#- 884908031157 Product Usage: Indicated for patient therapies requiring repeated access to the vascu
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.