7 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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Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJG·January 7, 2016
Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Recall
Terminated
·Customed, Inc Calle Igualdad Final # 7·Product code OJG·October 8, 2014
Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class I
·Terminated·Customed, Inc·December 10, 2014
NEURO SPINE PACK 3/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
FDA Enforcement
Class II
·Terminated·Customed, Inc·September 9, 2015
Catalog Number: 9001300 NEURO-SPINE SURGICAL PACK Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
FDA Enforcement
Class II
·Terminated·Customed, Inc·April 20, 2016
NEURO SPINE PACK - (1) BAG SUTURE FLORAL (1) COVER TABLE 44" X 90" (4) ABSORBENT TOWELS 15" X 20" UF (1) LAPAROTOMY T DRAPE 102" X 78" X 121" STD SMS (4) DRAPE UTILITY WITH TAPE LIF (3) GOWN IMP. EXTRA REINFORCED LARGE TIWRAP (1) DURAPREP SURGICAL SOLUTION 26mL UF (1) INCISION DRAPE 23" x 17" (1) INSTRUMENT POUCH (2) CAUTERY TIP POLISHER LIF (1) CAUTERY PENCIL HANDSWITCHING LIF (2) CONTAINER SPECIMEN 4oz WITH LID & LABEL (1) YANKAUER SUCT. TUBE WITHOUT VENT LIF (2) LITE GLOVES LIF (1) TUBE SUCTION CONNECT. Y.." X 12' LIF (1) SKIN MARKER WITH RULER (1) INCISE DRAPE ANTIMICROBIAL 23"x17" LIF (1) Pk SURGICAL STRIP W'X 6" (5) LAP SPONGES PRE-WASH 18" X 18" XRD L/F (20) GAUZE SPONGE 4"X 4" 16 PLY XRD LIF (1) SCALPEL WITH HANDLE #10 STAINLESS STEEL (5) DRAPE % ECONOMY 53" X 77" LIF (2) TABLE COVER HD 77" X 110" L!F (1) MAYO TRAY LARGE (1) UTILITY BOWL 16 oz LIF (2) NEEDLE & BLADE COUNTER 10c MAG/CLEAR L/F (2) SYRINGE 10cc WITHOUT NEEDLE LIL UF (1) SCALPEL WITH HANDLE #15 STAINLESS STEEL (1) J VAC RESERVOIR 300 mL 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
Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in combination with infusion pumps for continuous subcutaneous infusion of medication.
FDA Enforcement
Class II
·Terminated·Unomedical As·July 1, 2015