Devices

Warning Letter — Next Medical Products Company, LLC

Boston Scientific Cork, Ltd. — Class II: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195

Life Technologies Holdings Pte Ltd — Class II: Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent G

Boston Scientific Cork, Ltd. — Class II: Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195

Boston Scientific Cork, Ltd. — Class II: Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280

Boston Scientific Cork, Ltd. — Class II: Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195

Ventec Life Systems, Inc. — Class I: VOCSN (Japan) Model Number: PRT-01100-100, Package PN:PRT-01126-100. used for ventilator

Warning Letter — Peter Schiff Enterprises

Warning Letter — Chirp Innovations, LLC

Ferno-Washington Inc — Class II: Power F2 Powered Fastening System, Power F2, Item No. 0567093 used with Power X2 Stretcher

Instrumentation Laboratory — Class I: HemoslL AcuStar HIT-lgG(PF-4). Part Number: 0009802028. in vitro diagnostic (OUS only)

Howmedica Osteonics Corp. — Class II: Triathlon Hinge Femoral Prep Tray. Catalog Number: 6543-6-514.

Cook Incorporated — Class II: Williams Cystoscopic Injection Needles, used for cystoscopic injection into the urethra, b

Howmedica Osteonics Corp. — Class II: TS Universal Baseplate Finishing Tray, Triathlon. Catalog Number: 6543-6-506.

Medline Industries, LP — Class II: Medline surgical convenience kits labeled as: 1) OPEN HEART PACK A & B, Medline Produc

Warning Letter — Olympus Medical Systems Corporation

Stryker Sustainability Solutions — Class II: BARD EP XT DECAPOLAR STEERABLE, DIAGNOSTIC EP CATHETER, 6F, LARGE 4.0, 10, 2-5-2MM, REF: 2

PHILIPS MEDICAL SYSTEMS — Class II: Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X

Steris Corporation — Class II: VERIFY Biological Steam Test Pack Model/Catalog Number: S3065

Medline Industries, LP — Class II: Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame

Medtronic MiniMed, Inc. — Class II: Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MM

Onkos Surgical, Inc. — Class II: Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

ASP Global, LLC. — Class II: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 30" X 4" 2-LINE (CS 18)

Medline Industries, LP — Class I: Medline Basic Homecare Beds and Medlite Homecare Beds and Accessories MDR107000P BED, M

ASP Global, LLC. — Class II: Brand Name: Expressaire Product Name:DISPOSABLE BB TOURNQUET CUFF, 26" X 6" DUAL BLADDER,

Philips North America — Class II: Ingenia 3.0T and 3.0T CX; Model number (REF): 1. 781342 (3.0T), 2. 781377 (3.0T), 3. 7821

SPECTRUM MEDICAL SRL — Class II: Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High

ASP Global, LLC. — Class II: Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF, 8" X 2.5" 2-LINE (CS 12

Warning Letter — Unilam Co., LTD

Olympus Corporation of the Americas — Class II: Olympus BiCOAG Hemostasis Probe 7Fr Fixed Pin Connector. Model/Catalog Number: CD-B622LA.

Medline Industries, LP — Class II: Medline convenience kits containing Healthmark Instrument Channel Brushes. SINUS PACK DYNJ

Abiomed, Inc. — Class II: Automated Impella Controller (AIC) with the below product descriptions and corresponding P

Midmark Corporation — Class II: Midmark IQvitals Zone, automatically and noninvasively measures systolic and diastolic blo

CooperSurgical, Inc. — Class I: INCA (Infant Nasal Cannulae Assy) Neonatal Nasal CPAP, Replacement Set. Stay-Flex tubing c

Philips North America Llc — Class II: Achieva 3.0T; Model Numbers (REF): 1. 781177, 2. 781277, 3. 781278, 4. 781344, 5. 781345;

ENDOTAK RELIANCE (BOSTON SCIENTIFIC CORPORATION) — Malfunction

HD CAMERA HEAD (SHIRAKAWA OLYMPUS CO., LTD.) — Malfunction

FreeStyle Libre 2 Plus (Abbott Diabetes Care Inc) — Injury

EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE (SHIRAKAWA OLYMPUS CO., LTD.) — Malfunction

TENDRIL STS (Abbott Medical (CRM-Sylmar)) — Malfunction

Dexcom G7 15 Day Continuous Glucose Monitoring System (Dexcom, Inc.) — Malfunction

VISERA ELITE III VIDEO SYSTEM CENTER (SHIRAKAWA OLYMPUS CO., LTD.) — Malfunction

Datex-Ohmeda, Inc. — Class II: Et Control, Software option for anesthesia gas machine to achieve and maintain targeted en

GE Medical Systems Information Technologies Inc — Class II: Carescape Central Station CSCS V3 MAS800 Desktop Part Number 5867474-04, 5867474-13 P

Stryker Sustainability Solutions — Class II: REF:2B5ST Ethicon Endo-Surgery, Inc. XCEL BLADELESS TROCAR W/OPTIVIEW TECHNOLOGY & SLEE

AVID Medical, Inc. — Class I: Haylard 18G SINGLE SHOT EPI TRAY; Model/Item Number (Kit): DPGE002-02;

Datex-Ohmeda, Inc. — Class II: Aisys CS2 with Et Control, Datex-Ohmeda anesthesia system, Part Number 1011-9000-000

Medline Industries, LP — Class I: Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalo

Warning Letter — Lion Street Medical, d/b/a Pensar Medical LLC

Warning Letter — Specialty Health Products CO, LLC

Warning Letter — Advance-Esthetic LLC

C.R. Bard Inc — Class II: Products that contain the Pericare Wipes: SureStep" Foley Tray System Add-A-Foley Cathete

HeartSine Technologies Ltd — Class II: HeartSine SAM 350P 350P US Device, US English - 2 Min CPR UDI-DI codes: 0506016712067

Nipro Renal Soultions USA, Corporation — Class II: MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201

Atrium Medical Corporation — Class II: Getinge PVC Thoracic Catheter, Soft PVC Straight, 10 per Case; Size(Model Number): 1. 16F

Lutronic Corporation — Class II: Product Name: DermaV Laser System Model/Catalog Number: DermaV Medical laser device th

C.R. Bard Inc — Class II: Products that contain the Pericare Wipes: Bard¿ Foley Tray With Lubri-Sil¿ All-Silicone F

Medline Industries, LP — Class II: Medline Convenience Kits: 1) BLOOD CULTURE TRAY PEDIATRIC, Model Number: DYNDH1193; 2)

Cardinal Health 200, LLC — Class II: Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays: 1)

AVID Medical, Inc. — Class II: Halyard medical convenience kits labeled as: 1) A-P PACK - 205936, Model/Item Number (k

Fresenius Medical Care Renal Therapies Group, LLC — Class II: 5008X HD/HDF with Twister Blood Tubing Set Part Number 03-5350-8

Diagnostica Stago, Inc. — Class II: STA Staclot Protein S, Model/Catalog Number: 00746-Reagent Lot number 273074; qualitativ

Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) LAMI FUSION, Medline Kit SKU CDS982035Y; 2) N

IMRIS Imaging Inc — Class II: ORT200, operating room table, including the ORT200 Covered Table Assembly, Reconditioned,

Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) CMH LITHO MINOR PACK-LF, Medline Kit SKU DYNJ54

Medline Industries, LP — Class II: Medline breathing circuits labeled as: 1) HUDSON RCI, CIRCUIT, HTD, DL, NEONATE, 48, Me

Medline Industries, LP — Class II: Medline convenience kits labeled as: 1) MAJOR PROCEDURE, Medline Kit SKU CDS982040U;

IMRIS Imaging Inc — Class II: ORT300, operating room table, ORT300 Modular Table Main Unit Assy Part Numbers 114093-000

Vanta (MEDTRONIC PUERTO RICO OPERATIONS CO.) — Injury

STRATAFIX Symmetric PDS Plus (Ethicon Inc.) — Injury

FreeStyle Libre 2 (Abbott Diabetes Care Inc) — Malfunction

MiniMed 780G US System BLE Connect 3.0 mg/dL (Medtronic Puerto Rico Operations Co.) — Malfunction

HeartStart MRx monitor/defib (Philips North America LLC) — Malfunction

Covidien, LP — Class II: V-Loc 180 Absorbable Wound Closure Device BOX BEDSIDE STAPLING IS KING BOX06614V4

Medline Industries, LP — Class II: Medline Micro-Kill Bleach Germicidal Bleach Wipes, 12" x 12", 110 Count Bag, Product Numbe

W L Gore & Associates, Inc. — Class II: GORE VIABIL Short Wire Biliary Endoprosthesis, Model No. VSWVN1010. Flexible, self-expandi

MICROVENTION INC. — Class II: BOBBY Balloon Guide Catheter REF: BOB-895-CN BOB-895-EMEA BOB-895-EMEA-AL BOB-895-US

Cardinal Health 200, LLC — Class II: Cardinal Health Presource Kits: 1) ENT TRAY , Catalog Number: 24-0726

Cardinal Health 200, LLC — Class II: Cardinal Health Presource Kits: 1) HARMONIZED SPINE VCH PHC PACK , Catalog Number: SOP30S

Warning Letter — Nipro Renal Solutions USA, Corporation