Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 74 of 138
CareFusion 303, Inc.
Class II Terminated
Alaris Infusion Pump administration sets labeled as: -Infusion Set Alaris Pump Module/Medley Pump Module/Gemini Infusion Pump, REF 10011301, CareFusion, WARNING: TO PREVENT FREE-FLOW, CLOSE SET CLA...
Reason: Complaints where users were unable to prime the administration set.
Z-0385-2019 November 14, 2018 San Diego, CA
Becton Dickinson & Company
Class II Terminated
BD NEXIVA Closed IV Catheter System Dual Port 18GA 1.25 IN (BD Nexiva Catheter), Catalog Number 383539 Product Usage: BD Nexiva Closed IV Catheter System Dual Port (hereafter referred to as BD Ne...
Reason: One lot of the specified needles is not performing as intended due to a failure in the needle tip shield/safety mechanism, which may lead to an increased risk of a contaminated nee...
Z-0384-2019 November 14, 2018 Franklin Lakes, NJ
OriGen Biomedical, Inc.
Class I Terminated
REF VV19F Reinforced Dual Lumen Cannula, 19Fr., Sterile EO, DISPOSABLE: DO NOT RE-USE CE 0473 Product Usage: The OriGen RDLC catheter is indicated for use as a single cannula for both venous drai...
Reason: Potential for clear extension tube to separate from the hub, which could result in blood loss and may require intervention to prevent permanent impairment/damage
Z-0269-2019 November 14, 2018 Austin, TX
OriGen Biomedical, Inc.
Class II Terminated
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO
Reason: The catheter failed the endotoxin testing.
Z-0102-2019 October 24, 2018 Austin, TX
OriGen Biomedical, Inc.
Class II Terminated
Reinforced Dual Lumen Cannula, 23Fr., REF: VV23F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion ...
Reason: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Z-0182-2019 October 24, 2018 Austin, TX
OriGen Biomedical, Inc.
Class II Terminated
Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO; and ECMO Reinforced Dual Lumen Cannula, 13Fr., REF: VV13F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicat...
Reason: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Z-0179-2019 October 24, 2018 Austin, TX
OriGen Biomedical, Inc.
Class II Terminated
Reinforced Dual Lumen Cannula, 32Fr., REF: VV32F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion...
Reason: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Z-0184-2019 October 24, 2018 Austin, TX
OriGen Biomedical, Inc.
Class II Terminated
Reinforced Dual Lumen Cannula, 16Fr., REF: VV16F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion ...
Reason: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Z-0180-2019 October 24, 2018 Austin, TX
OriGen Biomedical, Inc.
Class II Terminated
Reinforced Dual Lumen Cannula, 19Fr., REF: VV19F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infusion...
Reason: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Z-0181-2019 October 24, 2018 Austin, TX
OriGen Biomedical, Inc.
Class II Terminated
ECMO Reinforced Dual Lumen Cannula, 28Fr., REF: VV28F, Sterile EO Indications: The OriGen Reinforced Dual Lumen Cannula is indicated for use as a single cannula for both venous drainage and re-infu...
Reason: These catheters may have the following deficiencies: 1) barium sulfate omission, and 2) actual catheter tip length is one centimeter shorter than printed on the tip
Z-0183-2019 October 24, 2018 Austin, TX
Sterilmed, Inc.
Class II Terminated
Reprocessed Agilis Steerable Introducer: indicated for introducing various cardiovascular catheters into the heart. (a) small curl (16.8mm curve type/71 cm length), Product Code STJ408309; (b) ...
Reason: Reprocessed Agilis Steerable Introducers may not meet endotoxin requirements per product specification for biological residues determined by LAL testing.
Z-0090-2019 October 17, 2018 Plymouth, MN
B. Braun Medical, Inc.
Class II Terminated
CONTIPLEX TUOHY SET, 18GX11/2X 1,3X40MM, Material Number 331695 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poi...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3321-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TKFMHDT 17 GA X 4 FULL EPID KIT, Material Number 332096 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point t...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3342-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TKFCPS EPIDURAL FULL TRAY, Material Number 332078 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a ca...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3332-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE18HB CONT EPIDURAL HUSTEAD, Material Number 332223 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a cat...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3365-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE18TKO PERIFIX ONE EPIDURAL FULL TRAY, Material Number 332282 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poin...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3379-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CONTIPLEX TUOHY ULTRA 4 IN CNB400TU, LF, Material Number 331691 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poi...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3318-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CONTI TUOHY ULTRA 360 2 IN CONT PNB SET, Material Number 331640 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poi...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3313-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CONTIPLEX TUOHY ULTRA 2 IN CONT. PNB SET, Material Number 331673 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access po...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3316-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE18TKY 18GA SAFETY TUOHY NEEDLE TRAY, Material Number 332266 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3378-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CE17TOD CONT EPIDURAL TRAY LF, Material Number 332235 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to a ca...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3372-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CONT STIM BASIC KIT W/4 IN INSUL TUOHY, Material Number 331758 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poin...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3327-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
EC19CF 19G X 100CM CATH CLOSED TIP LF, Material Number 333512 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3397-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
ES1827K SPINAL/EPIDURAL TRAY (LF), Material Number 333192 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access point to ...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3391-2018 October 10, 2018 Allentown, PA
B. Braun Medical, Inc.
Class II Terminated
CONTI CONT 4inTUOHY ULTRA 360 PNB TRAY, Material Number 332143 Connection device used by physicians to provide various anesthetic and fluid administration devices with a single, common access poin...
Reason: The catheter connectors may not stay closed during in and in some cases, leakage or disconnection of the catheters from the catheter connectors has been observed.
Z-3348-2018 October 10, 2018 Allentown, PA