MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, IC Tray REF: 8888102003HP
Reason: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter t...
Z-2371-2023August 23, 2023Mansfield, MA
Covidien LP
Class IOngoing
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 13 cm, Curved Extensions, IC Tray REF:8888101001HP
Reason: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter t...
Z-2367-2023August 23, 2023Mansfield, MA
Covidien LP
Class IOngoing
MAHURKAR 12 Fr High Pressure Triple Lumen Acute Dialysis Catheter, 20 cm, Straight Extensions, Kit REF: 8888340629HP
Reason: Catheter center lumen was found to have an occlusion in the tip of the catheter; the source of the occlusion an excessive MDX, a silicone-based lubricant which coats the catheter t...
Z-2379-2023August 23, 2023Mansfield, MA
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ART LINE KIT ICH OR, Model Number: ART900; b. ART LINE SECUREMENT KIT W/LIDOCAIN...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2292-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ABLATION PACK, Model Number: DYNJ40629B; b. AV FISTULA PACK, Model Number: DYN...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2312-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. A V FISTULA, Model Number: DYNJ65711; b. ACCESS CATHETER, Model Number: DYNJ64141A...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2305-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. ADULT EPIV INSERTION TRAY, Model Number: DYNDA2482; b. ARTERIAL LINE START KIT, ...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2323-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a.18G CPNB 20G STYLETED CATHETER, Model Number: DYNJRA1869; b. ACUTE PAIN BLOCK TRA...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2293-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. PEDIATRIC CATH ANGIO PACK, Model Number: DYNJ54755B; b. PEDIATRIC MAX BARRIER KIT-...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2321-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 16CM CENTRAL LINE BUNDLE, Model Number: STCVC2020; b. ARTERIAL LINE TRAY, Mode...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2304-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number: MNS10750A; b. STD INSERTIO...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2313-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CRMC MINOR IR PROCEDURE PK-LF, Model Numbers: DYNJ61099B, DYNJ61099C; b. CRMC TUNNE...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2298-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. 18GX6" FEMORAL ART LINE KIT, Model Number: ART960; b. 20Gx3" RADIAL ART LINE KIT, ...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2322-2023August 9, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Custom Sterile and Non-Sterile Procedural Kits containing Turkuaz Ultrasound Gel. Labeled as the following: a. CENTRAL CATHETER INSERTION TRAY, Model Number: CVI680C; b. CVC INSERTION ACCES...
Reason: Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications.
Z-2315-2023August 9, 2023Northfield, IL
Datascope Corp.
Class IIOngoing
MEGA 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description ...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2220-2023August 2, 2023Fairfield, NJ
Datascope Corp.
Class IIOngoing
SENSATION 7 Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description ...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2217-2023August 2, 2023Fairfield, NJ
Datascope Corp.
Class IIOngoing
MEGA 7.5Fr.IAB , Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description ...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2219-2023August 2, 2023Fairfield, NJ
Datascope Corp.
Class IIOngoing
LINEAR 7.5Fr.IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description ...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2223-2023August 2, 2023Fairfield, NJ
Datascope Corp.
Class IIOngoing
REINFORCED INTRODUCER SET, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description ...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2224-2023August 2, 2023Fairfield, NJ
Datascope Corp.
Class IIOngoing
YAMATO PLUS IAB; intra-aortic balloon catheter and accessories used to provide counter pulsation therapy in the aorta. Product Description ...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2216-2023August 2, 2023Fairfield, NJ
Datascope Corp.
Class IIOngoing
SENSATION PLUS 8Fr. IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description ...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2222-2023August 2, 2023Fairfield, NJ
Datascope Corp.
Class IIOngoing
SENSATION PLUS 7.5Fr IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description ...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2221-2023August 2, 2023Fairfield, NJ
Datascope Corp.
Class IIOngoing
TRANS-RAY IAB, Intra-Aortic Balloon Catheter and Accessories, used to provide counter pulsation therapy in the aorta Product Description Part Numb...
Reason: During IAB catheter insertion, the introducer dilator may fracture at the hub, leaving the body of the introducer dilator housed within the sheath. Risks to health include damage ...
Z-2218-2023August 2, 2023Fairfield, NJ
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: DIALYSIS ACCESSORY PACK W/O CATHETER, Model Number MNS10750A
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.
Z-2197-2023July 26, 2023Northfield, IL
MEDLINE INDUSTRIES, LP - Northfield
Class IIOngoing
Medline Probe Cover Kits containing sterile Ultrasound Gel, Labeled as the following: a) CVC PACK, Model Number DYNJ46967F; b) ENDOVENOUS CORE PACK, Model Number DYNJ62557; c) ENSEMBLE CATHE...
Reason: Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams.