Medical Device Recalls

39,072 Records

FDA medical device enforcement reports

3,445 results found for catheter Page 91 of 138
ICU Medical, Inc.
Class II Terminated
PROXIMALE - 28 cm (11") Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, NanoClave¿ (Red Rings), Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic devi...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2720-2017 July 19, 2017 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
Kit w/3 Ext Sets, 3 Drop-In MicroClave¿ Clear. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the administration of fluids from a container to a ...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2721-2017 July 19, 2017 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic device which provides access for the admin...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2723-2017 July 19, 2017 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, 0.2 Micron Filter, Clamp, Rotating Luer. Product Usage: The device is a single use, ster...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2724-2017 July 19, 2017 San Clemente, CA
ICU Medical, Inc.
Class II Terminated
10" Smallbore Ext Set w/6-Port NanoClave¿ Manifold (Orange, Red, Blue, Purple, Yellow Rings), Check Valve, Clamp, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogenic d...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2722-2017 July 19, 2017 San Clemente, CA
Arrow International Inc
Class II Terminated
Arrow Glide Thru Peel-Away Sheath/Dilator Introducer
Reason: Arrow is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away comp...
Z-2699-2017 July 19, 2017 Reading, PA
ICU Medical, Inc.
Class II Terminated
168 cm (66") Appx 2.6 ml, PVC/PUR Smallbore Ext Set w/6-Port NanoClave¿ Manifold, Check Valve, MicroClave¿ Clear, Rotating Luer. Product Usage: The device is a single use, sterile, non-pyrogeni...
Reason: The connection between the Female Luer and the NanoClave¿ manifold has the potential for developing a leak.
Z-2717-2017 July 19, 2017 San Clemente, CA
Boston Scientific Corporation
Class II Terminated
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inn...
Reason: A field report indicated some units within this lot were missing the bottom pouch seal. The compromised seal is completely missing and is obvious to the user.
Z-2645-2017 July 12, 2017 Maple Grove, MN
Boston Scientific Corporation
Class II Terminated
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 12-15mm Below UPN: M00547340
Reason: Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be a...
Z-2674-2017 July 12, 2017 Marlborough, MA
Sterilmed Inc
Class II Terminated
Electrophysiology catheter cables are designed as electrode cables with a multi-pin connector on the distal end and the appropriate number of tails on the proximal end. The cables serve two differ...
Reason: Sterilmed is recalling all lots of specific product codes of unexpired Sterilmed Reprocessed EP Ablation Cables because Sterilmed determined that the cables are Class III devices a...
Z-2669-2017 July 12, 2017 Minneapolis, MN
Boston Scientific Corporation
Class II Terminated
Boston Scientific Extractor Pro RX-S Retrieval Balloon Catheter 9-12mm Above UPN: M00547300
Reason: Label on the affected devices incorrectly identifies the injection location as "above" the balloon when it should be below the balloon and "below" the balloon when it should be a...
Z-2673-2017 July 12, 2017 Marlborough, MA
Merge Healthcare, Inc.
Class II Terminated
MasimoSET LNOP DCIP pediatric/slender digit SpO2 reusable sensor, finger clip pediatric (Merge Part Number: HW-HEMO-00076), Product Usage: Merge Hemodynamics monitors, measures, and records physio...
Reason: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Z-2642-2017 July 5, 2017 Hartland, WI
Merge Healthcare, Inc.
Class II Terminated
MasimoSET LNOP DCI adult SpO2 reusable sensor, adult finger clip (Merge Part Number: HW-HEMO-00075), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human ...
Reason: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Z-2643-2017 July 5, 2017 Hartland, WI
Merge Healthcare, Inc.
Class II Terminated
Masimo SPO2 Sensor, ear clip-adult (Merge Part Number: HW-HEMO-00047), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing a cardiac...
Reason: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Z-2641-2017 July 5, 2017 Hartland, WI
DeRoyal Industries Inc
Class II Terminated
DeRoyal(R) Dolphin Inflation Device, REF 0185ND, Rx Only, STERILE EO, Dolphin is an inflation device indicated during angioplasty procedures to inflate and deflate the balloon catheter, and control...
Reason: Lack of sterility assurance. There is a defect in the primary packaging of the device, which may compromise the device sterility
Z-2639-2017 July 5, 2017 Powell, TN
Merge Healthcare, Inc.
Class II Terminated
SpO2 connecting cable for Masimo LNCS sensor (Merge Part Number: HW-HEMO-00014), Product Usage: Merge Hemodynamics monitors, measures, and records physiologic data from a human patient undergoing ...
Reason: Under certain conditions, the cables used with the Hemo system during a patient procedure could stop displaying the patient SpO2 causing a slight delay in patient care.
Z-2640-2017 July 5, 2017 Hartland, WI
Vascular Solutions, Inc.
Class I Terminated
Venture RX Catheter, Model 5820; Venture OTW Catheter, Model 5821; Venture CS Catheter, Model 5822. Sterilized using ethylene oxide, Rx Only. The Venture catheter is indicated for directing, stee...
Reason: Vascular Solutions, Inc. (VSI) is voluntarily removing all lots of Venture catheters due to a potential problem. Venture RX (Model 5820), Venture OTW (Model 5821), and Venture CS ...
Z-2224-2017 June 28, 2017 Maple Grove, MN
Arrow International Inc
Class II Terminated
1) Introducer Kit with Integral Hemostasis Valve/Side Port, Sharps Safety Features, and Maximal Barrier Precautions for use with 7.5 - 8 Fr., Introducer Catheter 2) Arrow PSI Kit
Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Z-2329-2017 June 21, 2017 Reading, PA
Arrow International Inc
Class II Terminated
Arrow Pressure Injectable PICC Kit Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access t...
Reason: The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.
Z-2338-2017 June 21, 2017 Reading, PA
Arrow International Inc
Class II Terminated
Single-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter, Catheter, Percutaneous The Arrow Single-Lumen Catheter permits venous access to the central circulation
Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Z-2328-2017 June 21, 2017 Reading, PA
Arrow International Inc
Class II Terminated
Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R), ARROWg+ard Blue PLUS(R) Catheter and Sharps Safety Features. The multiple-lumen catheter permits venous access to the central circ...
Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Z-2332-2017 June 21, 2017 Reading, PA
Arrow International Inc
Class II Terminated
Arterial Catheterization Kit, Arterial Line Kit with Sharps Safety Features wire, guide, catheter The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or...
Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Z-2327-2017 June 21, 2017 Reading, PA
Arrow International Inc
Class II Terminated
1) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit 2) Pressure Injectable Multi-Lumen Central Venous Catheterization Kit with Blue FlexTip(R) Catheter and Sharps Safety Features 3...
Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Z-2330-2017 June 21, 2017 Reading, PA
Arrow International Inc
Class II Terminated
Arrow Multi-Lumen CVC Kit The Arrow Two-Lumen Central Venous Access device permits venous access and catheter introduction to the central circulation.
Reason: The Arrow CVC is indicated to provide short-term (<30 days) central venous access for treatment of diseases or conditions requiring central venous access including, but not limited...
Z-2336-2017 June 21, 2017 Reading, PA
Arrow International Inc
Class II Terminated
1) ARROWg+ard Blue You-Blend Two-Lumen Hemodialysis Catheterization Kit for High Volume Infusions The large-bore two-lumen catheter permits venous access to the central circulation for rapid fluid ad...
Reason: Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.
Z-2334-2017 June 21, 2017 Reading, PA