REF 20130-01 Spinning Spiros Closed Male Luer, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patients vascular system through the administration set...
Reason: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Z-1568-2021May 19, 2021San Clemente, CA
Bard Peripheral Vascular Inc
Class IITerminated
PowerPort duo M.R.I. Implantable Port, with attachable 9.5F Polurethane Open-Ended Dual-Lumen Venous Catheter, REF 1829570, UDI: (01) 00801741027192 - Product Usage: The port system can be used for in...
Reason: Catheters may experience difficulty in flushing, infusion, and/or aspiration, and septum dislodgements.
Z-1551-2021May 19, 2021Tempe, AZ
ICU Medical, Inc.
Class IIOngoing
REF CH2020 20mL Syringe w/Spinning Spiros, Red Cap - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s ne...
Reason: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Z-1576-2021May 19, 2021San Clemente, CA
ICU Medical, Inc.
Class IIOngoing
REF 20120-01 Spiros" Closed Male Luer - Product Usage: provides access for the administration of fluids from a container to a patient s vascular system through the administration set s needle or ca...
Reason: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Z-1585-2021May 19, 2021San Clemente, CA
ICU Medical, Inc.
Class IIOngoing
REF CH3235 30" (76 cm) Appx 4.1 ml, Yellow 20 Drop Admin Set w/15 Micron Filter, Spiros" - Product Usage: provides access for the administration of fluids from a container to a patient s vascular syst...
Reason: Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.
Z-1588-2021May 19, 2021San Clemente, CA
Cardiac Assist, Inc
Class IITerminated
Protek Solo Venous Dilator Set: dilator, vessel, for percutaneous catheterization. Catalog #: 5840-2417 - LS Tandem Life Kit - V24/A17 Catalog #: 5840-2415 - LS Tandem Life Kit - V24/A15 Catalog #...
Reason: On 02/26/2021, it was found that there were incorrectly packaged Dilator sets in Finished Goods. On 03/1/2021, it was confirmed that 14 kits containing the impacted products had be...
Z-1486-2021May 5, 2021Pittsburgh, PA
C.R. Bard, Inc.
Class IITerminated
Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only.
Reason: The device catheter tip was cut off (no tip) and the product packaging was not fully sealed.
Z-1431-2021April 28, 2021Covington, GA
Angiodynamics Inc. (Navilyst Medical Inc.)
Class IITerminated
AngioDynamics Safe Sheath Ultralite - Vascular Introducer/Catheter Introducer Catalogue #: VI10 - Product Usage: For the introduction of various types of pacing leads and catheters.
Reason: AngioDynamics, Inc. is recalling a specific batch of AngioDynamics Implantable Infusion Port kits and Valved introducers that may have potential for compromised sterility of the de...
Z-1467-2021April 28, 2021Glens Falls, NY
Trinity Sterile, Inc.
Class IITerminated
Midline Catheter Dressing Change Kit with Statlock - Product Usage: Intended to provide ongoing vascular catheter maintenance (e.g., dressing change, catheter flushing). Product Number: TRIO0000l
Reason: Evidence of face masks or other material in the seal in several kits, causing improper seals and compromised sterility
Z-1468-2021April 28, 2021Salisbury, MD
Boston Scientific Corporation
Class IITerminated
MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to th...
Reason: The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Z-1430-2021April 21, 2021Maple Grove, MN
Boston Scientific Corporation
Class IITerminated
MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are appl...
Reason: The firm initiated a removal of certain batches of MAMBA 135 and MAMBA Flex 135 Microcatheters due to incorrect labeling and packaging.
Z-1429-2021April 21, 2021Maple Grove, MN
Integra LifeSciences Corp.
Class IITerminated
CODMAN HAKIM BACTISEAL Shunt System Clear with Barium Stripe Peritoneal Catheter 120cm, with drainage Holes and Marking. For use in the treatment of hydrocephalus. Catalog Number: NS5524
Reason: Incorrect labeling, Catheter did not have the required holes and markings
Reason: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter ...
Reason: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter ...
Reason: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter ...
Z-1322-2021April 7, 2021Sunnyvale, CA
Oscor, Inc.
Class IITerminated
AngioDynamics SafeSheath ULTRALITE 10F, Model Number VI10 - Product Usage: intended for the introduction of various types of pacing leads and catheters.
Reason: Potential for open seal on sterile product
Reason: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter ...
Reason: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter ...
Reason: It has been identified that the catheter size on the packaging labeling does not correspond to the widest part of the catheter. In addition the IFU contains the incorrect diameter ...
Z-1321-2021April 7, 2021Sunnyvale, CA
Hollister Incorporated
Class IITerminated
Vertical Drain Tube Attachment Device (VTAD) (Gastrointestinal tube and accessories) - Product Usage: designed to stabilize and secure a variety of catheters, surgical drains, and tubes from sizes 5-4...
Reason: The tube holder can separate from the barrier that secures the device to the patients' body. The tube holder has the potential failure to separate from the barrier. This separatio...
Z-1311-2021April 7, 2021Libertyville, IL
TELEFLEX MEDICAL INC
Class IIOngoing
PLEUR-EVAC Thoracic Catheters (CATHETER, IRRIGATION). The thoracic catheter is a sterile, non pyrogenic, single use device that allows drainage from the mediastinum and/or the pleural space. The thora...
Reason: Teleflex is recalling this product due to a lack of assurance of sterility.
Z-1298-2021March 31, 2021Morrisville, NC
Epimed International, Inc.
Class IITerminated
Feth-R-Kath Catheter, 19g x 24". Intended Use:Radlo Opaque Epidural Catheter Catalog #: 157-1924 Intended for epidural anesthesia and is limited to placement of 72 hours or less
Reason: Outer coating of the catheter may deteriorate and result in the coating to crack and/or potentially flake off
Z-1276-2021March 24, 2021Johnstown, NY
Canon Medical System, USA, INC.
Class IIOngoing
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000F Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and ...
Reason: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Z-1271-2021March 24, 2021Tustin, CA
Canon Medical System, USA, INC.
Class IIOngoing
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000C Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and ...
Reason: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.
Z-1270-2021March 24, 2021Tustin, CA
Canon Medical System, USA, INC.
Class IIOngoing
Canon INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V Catheterization Table CAT-880B Canon CATHETERIZATION TABLE, MODEL CAT-880B INPUT 220V - Product Usage: indicated for use in diagnostic and...
Reason: System table may tilt because the bolts that fasten the vertical column and the table top tilting drive unit may become loose.