54 results
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10ms
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Sources: EU EUDAMED, US FDA
Myelo-Nate CSF Sampling Kit, Neonatal/Pediatric cerebralspinal fluid sampling sterile tray, including a lumbar puncture needle, four collection vials, an iodine swabstick package, a fenestrated drape, a polylined drape, three gauze pads, and one spot bandage.
FDA Enforcement
Class II
·Terminated·Utah Medical Products, Inc·November 18, 2015
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: IV START BOX, REF ACC010665
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: RETINAL PACK-LF, REF DYNJ0151148B
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
Combined Spinal and Epidural Anesthesia Tray 2, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: SESK. Product Description: SESK COMBINED SPINAL AND EPIDURAL TRAY 2.
FDA Enforcement
Class II
·Ongoing·B BRAUN MEDICAL INC·October 15, 2025
Combined Spinal and Epidural Anesthesia Tray, PERIFIX 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 27 Ga. x 5 in. (12.7 cm) Spinal Needle and 19 Ga. Open Tip PERIFIX FX Springwound Epidural Catheter. Product Code: NES1727KFX. Product Description: NES1727KFX W /17GA TUOHY 19GA SPRW OT.
FDA Enforcement
Class II
·Ongoing·B BRAUN MEDICAL INC·October 15, 2025
ESPOCAN Combined Spinal and Epidural Anesthesia Tray, ESPOCAN 17 Ga. x 3-1/2 in. (8.9 cm) Tuohy Epidural Needle, PENCAN 25 Ga. x 5 in. (12.7 cm) Spinal Needle with Marking and Centering Sleeve, and 19 Ga. Closed Tip PERIFIX FX Springwound Epidural Catheter. Product Code: ES1725KFX. Product Description: ES1725KFX ESPOCAN SPINAL/EPID. TRAY.
FDA Enforcement
Class II
·Ongoing·B BRAUN MEDICAL INC·October 15, 2025
Arrowgard Blue and Arrowgard Blue Plus Pressure Injectable Central Venous Catheter, a multiple-lumen catheter that permits venous access to central circulation. Catalog number ASK-45703-PHF.
FDA Enforcement
Class II
·Terminated·Arrow International Inc·May 28, 2014
BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN, REF: 386865; BD Cathena Safety IV Catheter 20GX1.00IN STRAIGHT BC, REF: 386803; BD Cathena Safety IV Catheter BD Multiguard Technology 20 GA x 1.00 IN, 386862
FDA Enforcement
Class II
·Ongoing·Becton Dickinson Infusion Therapy Systems, Inc.·May 28, 2025
Medline convenience kits containing BD Insyte Autoguard Shielded IV Catheters 22 GA x 1.00 IN. labeled as: 1) CC DRAWER 4 IV CIRCULATION, REF ACC010254B; 2) CC ADULT DRAWER 2, REF ACC010256; 3) PEDI EMERGENCY TRAY-BLUE, REF ACC010316A; 4) ADULT DRAWER 4, REF ACC010389C; 5) DRAWER 4 - SUMMIT, REF ACC010627; 6) DRAWER 3, REF ACC010898.
FDA Enforcement
Class II
·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·July 9, 2025
Introcan Safety 3 Closed IV Catheter 22 Ga. x 1 in., PUR, Winged. Passive safety IV catheter.
FDA Enforcement
Class II
·Ongoing·B Braun Medical Inc·March 26, 2025
Monoject" 201 Vet Pak Hypodermic Needle, 16 ga x 1-1/2 Item code: 8881201654
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·July 31, 2019
Monoject 201 Vet Pak Hypodermic Needle, 22 ga x 1-1/2" Item code: 8881201456
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·July 31, 2019
Monoject 201 Vet Pak Hypodermic Needle, 20 ga x 1-1/2" Item code: 8881201498
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·July 31, 2019
Monoject 201 Vet Pak Hypodermic Needle, 19 ga x 1-1/2 Item code: 8881201522
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·July 31, 2019
Monoject 201 Vet Pak Hypodermic Needle, 18 ga x 1-1/2 Item code: 8881201548
FDA Enforcement
Class II
·Completed·Cardinal Health 200, LLC·July 31, 2019
COUDE Blunt Nerve Block Needle, 10 units, 0.71mm (22 Ga) x 152mm, Each Unit Contains One Blunt Nerve Block Needle and One Wing, Sterile
FDA Enforcement
Class II
·Terminated·Epimed International·November 15, 2017
REF: 381923 BD Insyte Autoguard Winged Shielded IV Catheter, 22 GA x 1.00 in (0.9 x 25 mm) 35 mL/min, STERILEEO, RxOnly
FDA Enforcement
Class II
·Ongoing·Becton Dickinson Infusion Therapy Systems, Inc.·July 2, 2025
REF: 381434 BD Insyte Autoguard Shielded IV Catheter, 20 GA x 1.16 in (1.1 x 30 mm) 60 mL/min, STERILEEO, RxOnly
FDA Enforcement
Class II
·Ongoing·Becton Dickinson Infusion Therapy Systems, Inc.·July 2, 2025
REF: 382544 BD Insyte Autoguard Shielded IV Catheter, 18 GA x 1.16 in (1.3 x 30 mm) 95 mL/min, STERILEEO, RxOnly
FDA Enforcement
Class II
·Ongoing·Becton Dickinson Infusion Therapy Systems, Inc.·July 2, 2025
REF: 381533, BD Insyte Autoguard Winged, Shielded IV Catheter, 20 GA x 1.00 in (1.1 x 25 mm) 65mL/min, STERILEEO,RxOnly
FDA Enforcement
Class II
·Ongoing·Becton Dickinson Infusion Therapy Systems, Inc.·July 2, 2025