BEUDAMED
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    Bright Embrace, a Single Bili Light for newborn phototherapy Distributed by: Physician Engineered Products, Inc., Model SBL60

    FDA Enforcement
    Class II ·Terminated·Physician Engineered Products, Inc.·September 9, 2015

    Oxygen Masks- Labeling as follows: MADA, Inc. Adult Medium Concentration Oxygen Mask with Non-crush 7 Coiled Tubing, Connector Both Ends No 1327; RESPIREX Aerosol Mask Adult Elongated Manufactured for PSS World Medical Inc. RESPIREX Nebulizer Kits w/Aerosol Mask Adult 7 ft. (2.1m) Aerosol Tubing Manufactured for PSS World Medical Inc. Unomedical, Inc., Hospilak REF 100-E Aerosol Mask Adult Unomedical, Inc., Hospilak Ref. No. 101-E, Adult Aerosol Mask w/Aerosol Connector, 15 mm; Unomedical, Inc., Hospilak Ref. No. 102-E, Medium Concentration Mask, Adult 7 (2.1m) Tubing Unomedical, Inc., Hospilak Ref. No. 103-E, Medium Concentration Mask, Adult Unomedical, Inc., Hospilak REF 104-E High Concentration Rebreather Oxygen Mask, Adult w/7 (2.1)m) Oxygen Tubing, Unomedical, Inc., Hospilak Ref. No. 105-E, High Concentration Rebreather Oxygen Mask, Adult, No Tubing Unomedical, Inc., Hospilak Ref. No. 106-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 108-E, Oxygen Mask, Adult High Concentration Non-Rebreather 7 (2.1m) Oxygen Tubing Unomedical, Inc., Hospilak Ref. No. 118-E, Aerosol Mask Elongated, Adult 6 (1.8 m) Aerosol Tubing Unomedical, Inc., Hospilak Ref. No. 120-E, Venturi Mask Kit, Adult All Diluters No-Crush MADA INC. Aerosol Mask, Adult Size, Elongated MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use MADA INC. Aerosol Mask, Pediatric Size, Elongated No 1327 100% Latex Free MADA, Inc. 100% Latex Free, 1 unit per package/50 units per case Disposable Single Patient Use MADA INC. Up- Mist Medication Nebulizer With 7 ft. Oxygen Tubing and Elongated Aerosol Mask No. 1310MA 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use MADA INC Up-Mist Medication Nebulizer with 7 ft. Oxygen Tubing and Pediatric Aerosol Mask No. 1310 NMP 100% Latex Free 1 unit per package/50 units per case Disposable Single Patient Use Unomedical, Inc., Hospilak REF No. 131-E, Venturi Mask Kit, Adult with 31% diluter only, MADA, Inc. Child/Pediatric Medium Concentration Oxygen Mask with Non-Crush 7 Coiled Tubing, Connector Both Ends, NO 1327C, Unomedical, Inc., Hospilak REF No. 182-E, 3-in-1 Emergency Mask, Elongated Adult, 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 200-E, Aerosol Mask, Adult Small, No Tubing, Unomedical, Inc., Hospilak REF No. 202-E, Medium Concentration Oxygen Mask, Adult with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 220-E, Aerosol Mask, Pediatric, No Tubing, Unomedical, Inc., Hospilak REF No, 221-E, Aerosol Mask Elongated, Pediatric 5 (1.5m) Aerosol Tubing Unomedical, Inc., Hospilak REF No. 222-E, Medium Concentration Oxygen Mask, Pediatric with 7 (2.1m) Oxygen Tubing, Unomedical, Inc., Hospilak REF No. 223-E, Medium Concentration Oxygen Mask, Pediatric No Tubing, Unomedical, Inc., Hospilak REF No. 228-E, Up-Mist Nebulizer with 7 (2.1m) Oxygen Tubing, Pediatric Aerosol Mask Elongated Unomedical, Inc., Hospilak REF No. 245-E, Adult Trach Mask Unomedical, Inc., Hospilak REF No. 246-E, Pediatric Trach Mask Unomedical, Inc., Hospilak REF No. 260-E, Aerosol Mask, Infant No Tubing, Unomedical, Inc., Hospilak REF No. 263-E, Medium Concentration Mask Infant, No Tubing, Unomedical, Inc., Hospilak REF No. 282-E, 3 in 1 Emergency Mask, Elongated Pediatric, 7 (2.1m) Oxygen Tubing TRI-ANIM Adult Aerosol Mask Elongated adult aerosol mask with elastic strap and adjustable noseclip Part Number 301-170 50/case eValueMed Tri-anim Pediatric Aerosol Mask Elongated pediatric aerosol mask with elastic strap and adjustable noseclip Part Number 301-171 50/case eValueMed Tri-anim Adult Oxygen Mask Elongated adult medium mask with elastic strap and adjustable noseclip Part Number 301-180 eVal

    FDA Recall
    Terminated ·Convatec Inc.·Product code BYG·January 7, 2011

    Bard Mesh Monofilament Knitted Polypropylene; size 10 x 14", 3 units per box; Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    Bard Mesh Monofilament Knitted Polypropylene; Contents: size 2" x 4", 3 units per box, Davol Inc., A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    FDA Recall
    Terminated ·Ram Medical Inc·Product code FTL·March 5, 2010

    Bard RespiShield * Closed Suction System with InnoValve * Endotracheal Start Kit * QTY 1 Unit * 14F/4.7mm * Sterile * Rx Only * C.R.Bard, Inc., Covington, GA 30014, 800-526-4455, www. bardmedical.com * Manufactured in Mexico.

    FDA Recall
    Terminated ·C.R. Bard, Inc., Urological Division·Product code BSY·September 28, 2005

    Medefil Heparin I.V. Flush Syringe 1 units/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 units of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc. Glendale Heights, IL 60139. The pre-filled syringes were packed as 60 syringes per dispenser box, 16 boxes per shipping carton in the following syringe configurations: a) NDC# 64253-444-22, catalog # MIH-4422: 2 mL fill in 6 mL syringe; b) NDC# 64253-444-25, catalog # MIH-4425: 5 mL fill in 6 mL syringe

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·November 1, 2010

    Medefil Heparin I.V. Flush Syringe 1 unit/mL; a polypropylene luer locking syringe containing Heparin Lock Flush Solution, USP, a sterile non-pyrogenic, isotonic injection; each mL in a Heparin I.V. Flush Syringe contains 1 unit of heparin sodium derived from porcine intestinal mucosa and 9 mg of sodium chloride in water for injection; Medefil, Inc., Glendale Heights, IL 60139 The 5 mL fill in 6 mL syringes were packed 60 syringes per dispenser box, 16 boxes per shipping carton, NDC #64253-444-25, catalog #MIH-4425

    FDA Recall
    Terminated ·Medefil Incorporated·Product code NZW·March 20, 2008

    Blake Silicone Drain, 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code KOG·March 24, 2011

    Blake Cardio Connector 1 unit, Manufactured for: Ethicon, Inc. Somerville, New Jersey, 08876-0151. Closed Wound Drainage Systems have been used as an adjunct in the following specialties to evacuate potentially detrimental collection of certain fluids (e.g. pus, extravascular blood, bile) from wounds in body cavities and to reduce the risk of infection.

    FDA Recall
    Terminated ·Ethicon, Inc. US·Product code KOG·March 24, 2011

    SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 MAST ROLLER PUMP, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-00 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SRD S5 TWO MAST ROLLER PUMPS, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-60 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, S5 TWO MAST PUMPS 85 W/ COUPLING, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-62 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR S5 MAST ROLLER PUMP 85, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-70 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours.

    FDA Recall
    Terminated ·Sorin Group USA, Inc.·Product code DTQ·February 16, 2012

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

    FDA Recall
    Terminated ·ICU Medical Inc·Product code FRN·July 29, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 1.2 Micron Filter Set Non-Vented, Microbore 311 cm / 8.4 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case . Not distributed in the U.S.

    FDA Recall
    Terminated ·ICU Medical Inc·Product code FRN·July 29, 2019

    Infusion Pump I.V. Administration, specifically Sapphire Microbore Infusion Sets with Inline Filters labeled as SAPPHIRE Primary 0.2 Micron Filter Set Non-Vented, Microbore, 293 cm / 8.1 mL. 1 unit per pouch; 1 unit per blister; 40 blisters per case. Not distributed in the U.S.

    FDA Recall
    Terminated ·ICU Medical Inc·Product code FRN·July 29, 2019

    Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged MPS Console top covers)

    FDA Recall
    Terminated ·Quest Medical, Inc.·Product code DTR·December 17, 2019

    CRQ424, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·January 14, 2011

    CRQ423, Cardiac ResQ Kit, Quantity 3 units, KING SYSTEMS, A Consort Medical Company, Noblesville, IN 46060, www.kingsystems.com, 317-776-6823. Advanced Circulatory Systems, Inc., Eden Prairie, MN, www.advancedcirculatory.com, 877-7377763. This Oropharyngeal Airway is intended for airway management by providing a patent airway to allow patient ventilation. The sterile lubricant is used in Assembly Kits of the KLTD and the KLTSD products.

    FDA Recall
    Terminated ·King Systems Corp.·Product code CAE·January 14, 2011