Devices

Device Recall Customed

Model / Serial
Product code 900-414, 26 lots: 112030868 112041328 112051656 112062284 112072802 112093940 112104108 112114600 113015696 113025963 113036361 113036800 113057485 113068047 113068170 113088863 113089072 113099574 131110261 131210813 140111100 140211669 140311938 140412466 140412887 140513363
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
LAPAROSCOPY CHOLE PACK - - || ( 1) STRIP STERI CLOSURE W' X 4" LIF || ( 1) TABLE COVER REINFORCED 50" X 90" LIF || ( 1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" LIF || (2) GOWN LGE SMS IMPERVIOUS REINFORCED LIF || ( 1) GOWN XL SMS IMPERVIOUS REINFORCED L/F || (5) TOWELS ABSORBENT 15" X 20" LIF || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (4) DRAPE UTILITY WIT APE LIF || ( 1) COVER CAMERA W/ELAST LIF || (2) GAUZE SPONGE 4" X 4" 12PL Y LIF || ( 1) NEEDLE ULTRA VERES 120mm LIF || (2) DRAPE SHEET 41 " X 58" SMS LIF || ( 1) SCALPEL WEIGHTED SAFETY #11 || ( 1) TUBING INSUFFLATING OPEN TIP W/0 VENT LIF || ( 1) DRESSING TEGADERM 4" X 4 %" LIF || ( 1) TUBE SUCTION CONNECT X" X 12' LIF || ( 1) MAYO STAND COVER REINFORCED LIF || ( 1) SUTURE BAG FLORAL LIF || ( 1) Pk. STERI STRIP LAP SET LATEX || ( 1) CORD LAPAROSCOPY MONOPOLAR LIF || ( 1) MAYO TRAY SMALL LIF || ( 1) TIME OUT BEACON NON WOVEN ST. LIF || (1) SKIN MARKER INK W/8 LABEL TIME OUT/RULER LIF || ( 1) BAG ZIP LOCK PLASTIC 6" X 10" || 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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