Devices

Device Recall Customed

Model / Serial
Product code 900-1300, 20 lots: 109050993 112051747 112093868 112104141 112124943 113015633 113025937 113036226 113046883 113047325 113057419 113078249 113099270 113109990 131110171 140111097 140211640 140312065 140412551 140513082
Product Classification
Neurological Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Product Description
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.
Manufacturer
Customed, Inc
1 Event
- Recall of Device Recall Customed

Manufacturer

Customed, Inc

Manufacturer Address
Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
Manufacturer Parent Company (2017)
Customed Inc
Source
USFDA

331 devices with a similar name

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Device Recall Customed

Model / Serial
Product code 900-002, 26 lots: 112020289 112030605 112041383 112051709 112061653 112062296 112072757 112093974 112104120 112124901 113015421 113015629 113026199 113036745 113057404 113057683 113068134 113078451 113078655 113099260 131110394 131110574 140211618 140211908 140513048 140613547
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Product Description
Customed Angiodrape Pack || convenience pack include multiple components: syringe 10cc and 30cc, gauze, denture cup, specimen container, band bag, glove, gown, needle hypodermic, absorbent towels, table cover, scalpel,cloth huck towel,iodine povidone,applicator sponge,towel clamp, femoral angiography drape,needle 18G,& Guidewire || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
Product code 900-164, 14 lots: 110061393 113046935 113047213 113047335 113057700 113068153 113109743 131110191 131110600 140111164 140211648 140311924 140513392 140513453
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Product Description
Customed Femoral Pack , convenience pack include multiple components: Syringe 3cc, 5cc, 10cc, 20cc; swabstick chlorascrub, needles, gauze/sponges, table cover, absrobent towels, halsted Mosquito CVD, gown, bowls, wrapper, scalpel safety, Mosquito forcep, cloth huck, clamp towel, fluorocover, medicine cup, femoral angiodrape, mayo tray, counter & labels. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
Product code 900-012, 24 lots: 113036306 113015685 112030796 112041172 112062299 112083042 112051659 112093835 113046992 113047150 113015422 113057828 112124902 131110142 113089148 113099380 113078658 131210664 140111130 140211621 140311909 140412444 140513051 140613549
Product Classification
Obstetrical and Gynecological Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Product Description
Customed O.B. Pack || convenience pack include multiple components: set up cover, absorbent towel, ear ulcer syringe, pad, umbilical cord clamp, wash basin, baby blankets, table cover, gauze sponge, syringe 10CC w/o needle & 10CC with needle, feeding tube, drape, legging with cuff, underbuttock drape, gown, container with lid, mayo tray, receiving blanket, & baby beannies. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
Product code 900-028, 30 lots: 111071871 112041386 112041433 112051660 112051712 112062301 112062560 112093834 112124408 112124903 112125312 113015686 113026162 113036772 113047331 113057830 113068022 113068136 113078564 113089015 113089177 113099559 131110062 131110395 131110575 140111089 140111447 140211739 140312327 140513052
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Product Description
Customed Laparoscopy convenience pack include multiple components: gowns, table covers, needle and blade counter, bag suture, suture, sponges/gauzes, containers, syringes 20cc & 30cc w/o needle, needle, drape, tubing, towel, dressing island, and blade surgical SS. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
Product code 900-036, 34 lots: 111113166 111123284 112010009 112010241 112020297 112030608 112041067 112051663 112062306 112062580 112072761 112093837 112114906 113015423 113025923 113026201 113036746 113057376 113057765 113068023 113068137 113078565 113089178 113099560 131110082 131110396 131110576 131210954 140111448 140211910 140312429 140412881 140513056 140513343
Product Classification
Gastroenterology-Urology Devices
Device Class
1
Implanted device?
No
Distribution
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Product Description
Customed Major Laparotomy Pack , convenience pack include multiple components: Mayo stand cover, absorbent towel, bag suture, drape, suction tube, lite glove, gauze/sponges, drape, surgical blades, utility bowls, towels, tube suction, cautery tip, gown, and labels. || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Manufacturer
Customed, Inc

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Disclaimer

Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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