AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205...
Reason: There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through ...
Reason: The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Reason: The Cardiosave IABP may shut down unexpectedly due to blood entering in the Cardiosave IABP when therapy is provided with a compromised intra-aortic balloon catheter.
Z-0885-2023January 25, 2023Mahwah, NJ
Stradis Healthcare
Class IIOngoing
Stradis Healthcare Foley Catheter Insertion Tray with preconnected bag and catheter, Sterile
Reason: Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.
Z-0931-2023January 18, 2023Waukegan, IL
Covidien LP
Class IOngoing
MAHURKAR 13.5Fr High Flow Dual Lumen Acute Dialysis Catheter, Sterile, Single Use, Rx Only: 13.5cm, Straight Extensions, Kit - Model No. 8888135131; 13.5 cm, Curved Extensions, Kit - Model No. 8...
Reason: There is a potential leaking condition within the hub of affected devices, due to an inter-lumen void in the hub component, which may result in unanticipated fluid return during us...
Reason: The product is labeled with the incorrect expiration date.
Z-0955-2023January 18, 2023Minneapolis, MN
Medical Action Industries, Inc. 306
Class IITerminated
Medical Action INDUSTRIES INC. Port a Cath Kit REF 58647D, cardiac catheter introduction kit
Reason: XXX
Z-0751-2023December 28, 2022Arden, NC
Cordis US Corp
Class IIOngoing
Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector to the catheter for injection into the patient.
Reason: There is a potential for separation at the male connector.
Z-0720-2023December 21, 2022Miami Lakes, FL
ARROW INTERNATIONAL Inc.
Class ITerminated
Arrow MAC Two-Lumen Central Venous Access Kit fr use with 7 - 7.5 Fr Catheters, REF ASK-11242-UPM1; catheter introducer
Reason: There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access K...
Z-0351-2023December 21, 2022Morrisville, NC
ARROW INTERNATIONAL Inc.
Class ITerminated
Pressure Injectable Arrowg+ard Blue Plus Three-Lumen CVC Kit, REF numbers: a) ASK-42703-NS, b) ASK-42703-PCCH2, c) ASK-42703-PUPM1, d) ASK-45703-NS, e) ASK-45703-PAU, f) ASK-45703-PCAM1, g) ASK-45703-...
Reason: There is the potential for inadequate connection between the top and bottom housings of the Micro Clave Clear Connectors included in the Arrow MAC Two-Lumen Central Venous Access K...
Z-0352-2023December 21, 2022Morrisville, NC
Elekta, Inc.
Class IIOngoing
Oncentra Brachy radiation therapy planning system software.
Reason: A reconstruction error may occur when using the Catheter Bending functionality in Applicator Modeling or Implant Modeling
Z-0719-2023December 21, 2022Atlanta, GA
Cardinal Health
Class IIOngoing
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended for urinary drainage from the bladder of a patient
Reason: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria...
Z-0358-2023December 14, 2022Mansfield, MA
Cardinal Health
Class IIOngoing
Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for urinary drainage from the bladder of a patient
Reason: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria...
Z-0357-2023December 14, 2022Mansfield, MA
Cardinal Health
Class IIOngoing
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450LF Intended for urinary drainage from the bladder of a patie...
Reason: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria...
Z-0361-2023December 14, 2022Mansfield, MA
Bunnell, Inc.
Class IIOngoing
2.5 mm LifePort Endotracheal Tube Adapters 10-pack, Catalog: 9025; and 2.5 mm LifePort Endotracheal Tube Adaptors inside Patient Circuit Kits, Catalog: 938
Reason: Some adaptors, for use with high frequency ventilators, were packaged improperly, and may deform at the tip, which may impair the ability to pass a suction catheter or may affect n...
Z-0371-2023December 14, 2022Salt Lake City, UT
Cardinal Health
Class IIOngoing
Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of a patient
Reason: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria...
Z-0359-2023December 14, 2022Mansfield, MA
Cardinal Health
Class IIOngoing
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag Product Code: 3450 Intended for urinary drainage from the bladder of a patient
Reason: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria...
Z-0360-2023December 14, 2022Mansfield, MA
Cardinal Health
Class IIOngoing
Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinary drainage from the bladder of a patient
Reason: Occlusion (blockage) of the bubble inlet port of the urinary drainage bag which may prevent urine draining into the bag. If the bladder is not emptied within a clinically appropria...
Z-0356-2023December 14, 2022Mansfield, MA
Medical Action Industries, Inc. 306
Class IITerminated
B. Braun CARESITE Port Access Kit w/Tegaderm, REF 375214, Central Venous (cardiac) Catheter Tray (REF number corrected 11/23/2022)
Reason: The kits were incorrectly labeled with an extended expiration date of 02/21/2024 instead of 02/10/2024.
Z-0265-2023November 30, 2022Arden, NC
Pajunk Medical Systems, L.P.
Class IITerminated
PAJUNK Continuous Epidural Tray, Tuohy Epidural Needle 17G x 4" with EpiLong Soft Catheter, Closed Tip, 19G, Model #TAL101, sterile, each tray contains 5ml Ampule 1% Lidocaine HCl, 10ml Ampule 0.9% So...
Reason: The tray contains a 2ml ampule of 0.75% Marcaine Spinal in lieu of a 10ml ampule of 0.9% Sodium Chloride as intended,.
Z-0278-2023November 30, 2022Alpharetta, GA
TELEFLEX LLC
Class IIOngoing
Teleflex Medical RUSCH Pocket Pac i.c. Closed System Intermittent Catheter Kit, 14 Fr (4.7mm), REF 10096140 (IPN050116). Urinary catheter.
Reason: Product may not be sterile
Z-0227-2023November 23, 2022Morrisville, NC
LeMaitre Vascular, Inc.
Class IIOngoing
TufTex Embolectomy Catheter, Model No. This catheter has a latex balloon and a single lumen extrusion. It is inserted using a guidewire or introducer. The devices affected by this recall are 3F an...
Reason: Three lots tied by two trainees were released without performing the required pull test. If tied with inadequate strength, the proximal ligature could slip toward the tip of the ca...
Z-0228-2023November 23, 2022Burlington, MA
Access Vascular, Inc.
Class IITerminated
Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central Catheter
Reason: Scalpel and StatLock components packaged with specific lots of the HydroPICC catheter have a shorter expiration date than what is listed on the outer kit package.
Z-0199-2023November 16, 2022Billerica, MA
Becton Dickinson Infusion Therapy Systems Inc.
Class IIOngoing
BD Nexiva Closed IV Catheter System - Single Port REF 383516 20 GA X1.0o in (1.1 x 25 mm) 61 mL/min (3660 mL/hr)
Reason: During needle withdrawal, the tip shield may prematurely separate from the catheter adapter and preventing the needle tip from being in the safely shielded (leaving the needle tip ...
Z-0174-2023November 9, 2022Sandy, UT
Edwards Lifesciences, LLC
Class IIOngoing
Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP
Reason: Due to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches.