74 results
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11ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
FDA Enforcement
Class II
·Terminated·CMP Industries, Llc·March 16, 2016
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
FDA Enforcement
Class II
·Terminated·Wexford Labs Inc·November 27, 2013
5 Qt. Wallmount Sharps Container, Model 150, Regular Size; colors 202 Beige, 030 Red, 040 Yellow, 24 count containers; Made in USA for: Medline Industries; BEMIS label has Manufactured by Bemis Mtg. Co., Sheboygan Falls, WI.
FDA Recall
Terminated
·Bemis Health Care, Inc·Product code MMK·August 23, 2006
Ready to Use Thymo-Cide, Germicidal Detergent, containing 0.051% thymol, packaged in 1-qt. bottles. The firm name on the label is Wexford Labs, Inc., Kirkwood, MO. For disinfection of hard, non-porous surfaces (floors, walls, tables, etc.) in operating rooms, intensive care, nurseries, emergency areas, dental operatories, police, EMS, and all health care facilities.
FDA Recall
Terminated
·Wexford Labs Inc·Product code LRJ·September 10, 2013
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing a fractured denture, or forming a new denture base.
FDA Recall
Terminated
·CMP Industries, Llc·Product code EBI·November 18, 2013
UROLOGY PACK - (3) TOWELS ABSORBENT 15" X 20" UF (1) WASH BASIN ROUND 6QT. (1) SYRINGE 30cc W/O NEEDLE LUER LOCK UFN (1) BAG URINARY DRAINGAGE 2000ml ANTI-REFLUX (1) BAG SUTURE FLORAL (1) GOWN SURG. REINFORCED X-LARGE T/VIJRAP (1) TABLE COVER 44" X 90" UF (2) DRAPE SHEET 42" X 55" SMS UF (1) TUBE SUCTION CONNECT. Y." X 12' UF (1) MAYO STAND COVER REINFORCED UF (10) GAUZE SPONGE 4" X 4" 16PLY (1) GOWN X-LARGE SMS IMPERVIOUS REINFORCED (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL (1) TUR Y SET TWO LEAD ST. UF (1) DRAPE LITHO 110" X 63" SMS WITH LEGGINS EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
REYITO UROLOGY PACK - (2) GOWN IMP. REINFORCED X-LARGE SMS (2) TOWELS ABSORBENT UF ( I) URINARY DRAIN. BAG 2000ML ANTI-REFLUX UF ( I) SYRINGE 30cc W/0 NDL. LUER LOCK UF ( I) BAG SUTURE (I) TABLE COVER ( I} TUBE SUCTION CONNECT. W' X 12' UF (10) GAUZE SPONGES 4" X 4" 16PLY ( I) EMESIS BASIN (I) DRAPE LASER CAMERA W/E ( I} UTILITY BOWL32oz (I) BOWL PLASTIC 80oz WITH LID ( I) SYRINGE IOcc W/0 NDL. LUER LOCK UF (I} SYRINGE IOcc PREFILLED WITH GEL (5) CONTAINER SPECIMEN 4oz W/LID & LABEL (I) GOWN SURG. REINFORCEDT/WRAP X-LARGE ( I} TUR Y SET, 2LEAD UF ( I} DRAPE LITHO 11 0" X 63" WI POUCH WILEGGING ( I} ROUND WASH BASIN 6QT. EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
0.B. PACK - - (1) TABLE COVER 44" x 90" (1) UNDERBUTTOCK DRAPE WITH POUCH (2) LEGGINS WITH 7" CUFF 30" x 42" (1) GOWN IMPERVIOUS REINFORCED LARGE SMS (3) TOWELS ABSORBENT 15" x 20" (1) PAD OBSTETRICAL X-LARGE (1) VAGINAL SPONGE XRD (10) GAUZE SPONGES 4" X 4" 12PLY XRD (1) CORD UMBILICAL CLAMP (1) BABY BLANKET PRINTED (2) EAR/ULCER SYRINGE 2oz (1) SET UP COVER CLEAR POLY (1) BASIN WASH 7QT. (1) ABDOMINAL DRAPE WITH TAPE LIF (2) KELLY FORCEP STRAIGHT 5 % (1) MAYO SCISSOR STRAIGHT 6% (1) BABY BEANNIES EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
UROLOGY PACK - (4) ABSORBENT TOWELS UF (2) GOWN SURGICAL POLY-REINF. BREATHABLE XL LEVEL IV (1) SYRINGE 30cc WITHOUT NDL LUER LOCK L/F (1) TUR Y SET, 81 "2 .1M REGULAR CLAM (1) TABLE COVER 44" x 90" (1) DRAPE LITHO 11 0" X 63" WITH POUCH /LEGGING FEN (1) TUBE SUCTION CONNECT. Y." X 12' LIF (1) WASH BASIN ROUND 6QT (1 0) GAUZE SPONGE 4" X 4" 16PL Y LIF (1) BAG URINARY DRAINAGE 2000ml ANTI-REFLUX LIF (1) DRAPE LASER CAMERA W/EL UF (1) SYRINGE 1 Occ W/0 NDL LUER LOCK UF (1 ) UTILITY BOWL 32oz. (1) GEL SYRINGE 10cc PREFILLED (5) SPECIMEN CONTAINER 4oz. W/LID & LABEL L/F (1) WRAPPER 20" X 20" L/F EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
FDA Enforcement
Class I
·Terminated·Customed, Inc·September 10, 2014
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 100 units/ml in 0.9% Sodium Chloride 120/Case, Catalog #1003-02, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0903-12, NDC #64054-0903-2, 3 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513612, NDC #64054-1003-02, 5 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Normal Saline IV Flush, REF #513584, NDC 64054-0903-2, 3 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524.
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
B. Braun, Normal Saline IV Flush, REF #513587, NDC 64054-0910-2, 10 mL fill in a 12mL syringe, 120/Case, Single Use Only, Rx Only, Distributed by: B. Braun Medical, Inc., Bethlehem, PA 18018-3524
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM Flex Solo II images small body parts with optimized PET technology.
FDA Recall
Terminated
·Naviscan PET Systems·Product code KPS·June 19, 2008
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0905-12, NDC #64054-0905-2, 5 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use Only, Rx only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
PEMView Software used with Naviscan PEM Flex Solo I and PEM Flex Solo II PET Scanner, for nuclear medicine imaging.
FDA Recall
Terminated
·Naviscan PET Systems·Product code KPS·August 1, 2007
B. Braun, Heparin Lock Flush Solution USP, 100 units/ml, 120/Case, Ref #513611, NDC #64054-1003-01, 3 mL Fill in a 12mL Syringe, For Single Use only, Sterile Solution Pathway, For IV Flush, Distributed by B. Braun Medical, Inc., Bethlehem, PA 18018
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Heparin Lock Flush Solution USP, 10 units/ml, Catalog #3003-06, NDC #64054-3003-06, 3mL Fill in a 6mL Syringe, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007
Sierra Pre-Filled, Normal Saline IV Flush, Catalog #0910-12, NDC #64054-0910-2, 10 mL Fill in a 12mL Syringe, 0.9% Sodium Chloride Injection USP, 120/Case, For Single Use only, Sterile Solution Pathway, For IV Flush, Sierra Pre-Filled Inc., 455 W. Depot St. Angier, NC 27501
FDA Recall
Terminated
·AM2 PAT INC·Product code FOZ·December 11, 2007