Device Recall Customed

Model / Serial
Product code 900-1717, 49 lots: 109102292 109112479 109122763 110030824 110040903 110061439 110071672 110081970 110082178 110092389 110112617 110122925 111010065 111020275 111030600 111051279 111061510 111071778 111082063 111092363 111102698 111113030 111123378 112010085 112020403 112030641 112041198 112051872 112062446 112072784 112083404 112093911 112104294 112114647 112125031 113036755 113057397 113067893 113078272 113088758 113089199 113099389 131110197 131210759 140111170 140312083 140412457 140513109 140613626
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
O.B. PACK - || (I) TABLE COVER REINFORCED 50" X 90" LIF || (I) DRAPE UNDERBUTTOCK WITH POUCH 44" X 35" || (2) LEGGINS W/7'' CUFF 30" X 42" || (1) GOWN LARGE SMS IMPERVIOUS REINFORCED || (3) TOWELS ABSORBENT 15" X 20" LIF || (I) PAD OBSTETRICAL X-LARGE ST. || (I) PACKING VAG JNAL 4" X 36" 8PL Y XRD || (10) GAUZE SPONGES 4" X 4" 12PLY XRD || (I) UMBILICAL CORD CLAMP || (1) BABY BLANKET PRINTED || (2) EAR/ULCER SYRINGE 2oz. LIF || (I) COVER SET UP 42" X 75" CLEARPOLY || (1) DRAPE ABDOMINAL WITH TAPE L/F || (1) BOWL WITH LID PLASTICS 80oz. L/F || (1) SHEET DRAPE 41" X 58" SMS LIF || 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 900-2259, 17 lots 112083065 112114604 113015509 113025814 113036344 113046904 113056793 113057467 113067917 113078474 113088795 113099487 113109794 131110245 131210648 131211017 140211501
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
LAPAROSCOPIA COLORECTAL PACK || CONTENTS: || (1) SOLUTION SURGICAL DURAPREP 26ml || (4) DRAPE UTILITY WITH TAPE || (1) TOWELS ABSORBENT 15" X 20" || (2) LEGGINS W/7" CUFF 30" X 42" || (1) BLADE SURGICAL #15 STAINLESS STEEL || (1) BLADE SURGICAL #11 STAINLESS STEEL || (1) GOWN IMPERV. EXTRA REINFORCED XLG || (1) GOWN LGE STANDARD SMS VELCRO NECK || (1) IRRIGATION SUCTION TROMPET DUAL SPIKE (10) GAUZE SPONGE 4" X 4" 16PLY XRD || (2) UTILITY BOWL 16oz || (2) STERI STRIP CLOSURE W' X 4" || (1) ACTIFOG W/FOAM PAD SOLUTION || (1) TABLE COVER REINFORCED 50" X 90" || (1) MAYO STAND COVER REINFORCED || (1) NEEDLE ULTRA VERES 120MM || (1) STAPLE ARTICULATING ECHEL 60MM || (1) RELOAD WHITE 60MM ECHELON || (1) RELOAD BLUE 60MM ECHELON || (2) CANNULA 5MM XCEL SLEEVES || (1) TROCAR 5MM BLADELE WITH STAB SLEEVE || (1) TROCAR 12MM BLADELE WITH STAB SLEEVE || (1) DRAPE LAP. ABDO W/POUCH 102" X 122" X 78" STD SMS || Product Usage: || 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 900-2259A, 3 lots 140312025 140412651 140612902
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 COLORECTAL SURGICAL PACK || CONTENTS: || (1) SOLUTION SURGICAL DURAPREP 26ml LIF || (4) DRAPE UTILITY WITH TAPE LIF || (3) TOWELS ABSORBENT 15" X 20" LIF || (2) LEGGINS W/7'' CUFF 30" X 42" LIF || (1) BLADE SURGICAL# 15 STAINLESS STEEL || (1) BLADE SURGICAL# 11 STAINLESS STEEL || (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Ill LIF || (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (2) UTILITY BOWL 16oz. LIF || (2) PK. STERI STRIP CLOSURE%'' X 4" L/F || (1) ACTIFOG WITH FOAM PAD SOLUTION LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) NEEDLE ULTRA VERES 120MM LIF || (1) STAPLE ARTICULATING ECHEL 60MM LIF || (1) RELOAD WHITE 60MM ECHELON L/F || (2) CANNULA 5MM XCEL SLEEVES LIF || (1) TROCAR 5MM BLADELE W/STAB SLEEVE UF || (1) TROCAR 12MM BLADELE W/STAB SLEEVE LIF || (10) LAP SPONGES PREWASH 18" X 18" XRD LIF || (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR LIF || (2) LITE GLOVE || (1) PENCIL CAUTERY ROCKER SWITCH WITH HOLSTER LIF || (1) ELECTRODE DUAL DEPRES || (1) LAPAROSCOPIC/LITHOTOMY DRAPE WITH CLEAR INSTRUMENT POUCHES || (1) COUNTER NDLE/BLADE 20C FOAM/MAG LIF || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER LIF || (1) BAG SUTURE FLORAL || (1) GOWN IMPERV EXTRA REINFORCED LARGE TOWEL& WRAP LIF || (1) POLISHER CAUTERY TIP LIF || (1) BAG GLASSINE || (1) RELOAD BLUE 60MM LIF || (1) TIME OUT BEACON NON WOVEN LIF || Product Usage: || 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 900-2262,8 lots 112041231 113036345 113047112 113078310 113088797 140111207 140211823 140312128
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
CENTRAL LINE FULL BODY DRAPE || CUSTOMED || CONTENTS: || (1) WRAPPER 30" X 30" || (2) MASK SURGICAL W/ VISOR ANTI-FOG 160mm Hg || (2) CAP NURSE 21" GREEN BOUFFANT (2) TOWELS ABSORBENT 15" X 20" || (2) GOWN LARGE STANDARD SMS VELCRO/NECK (1) DRAPE SHEET 41" X 58" SMS || (1) DRAPE BRACHIAL ANGlO 44" X 31" REINFORCED 3" ADHESIVE CIRCULAR FENESTRATION || Product Usage: || 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 900-2270,1 lot 112125073
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 SYSTEM PACK || MIAMI METRO || CON TENTS: || (12) TOWELS CLOTH HUCK BLUE LIF || (1) MAYO STAND COVER REINFORCED LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SUTURE BAG FLORAL LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF (1) BULB SYRINGE 60cc LIF || (1) BLADE SURGICAL #10 STAINLESS STEEL || (2) SHEET% 60" X 77" DRAPE REINFORCED LIF (10) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) BLADE SURGICAL #15 CARBON STEEL (1) TUBE SUCTION CONNECT Y." X 12' LIF (1) BAG GLASSINE PLAIN || (1) CAUTERY TIP POLISHER LIF || (1) DRAPE LAP. ABDOMINAL WITH POUCH 102" X 122" X 78" LIF (1) PK. STRIP STERI CLOSURE W' X 4" LIF || (1) SKIN MARKER INK WITH 8/LABEL/TIME OUT/RULER L/F (1) CORD LAPAROSCOPY MONOPOLAR FOOD SWICHING (1) COUNTER NEEDLE BLADE 30c MAG/FOAM || (1) TIME OUT BEACON NON WOVEN LIF || (1) GOWN XL SMS IMPERVIOUS REINFORCED LIF || (1) GOWN SURG. REINFORCED X LARGE TOWEL/WRAP LIF (1) TOWEL ABSORBENT 15" X 20" LIF || (1) BLADE SURGICAL #11 CARBON STEEL || (1) TUBING INSUFFLATION OPEN TIP WITHOUT VENT LIF (1) YANKAUER OPEN TIP CLEAR WITHOUT C IV LIF || ATTACHED PACK WITH THE FOLLOWING STERILE COMPONENT: (1) ACTIFOG WITH/FOAM PAD SOLUTION LIF || Product Usage: || 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 900-2284 ,5 lots 112083036 112125074 113026297 113057619 113078727
Product Classification
Orthopedic 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
LUMBAR PACK || ADVANCED AMBULATORY SURGICAL CENTER || CONTENTS: || (1) COVER TABLE REINFORCED 50" X 90" UF (4) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (8) TOWELS CLOTH HUCK BLUE UF (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK UF (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF (1) STRIP STERI DRAPE LARGE 17" X 23" UF || (1) SCALPEL WITH HANDLE #11 (1) COVER FLUORO 30" X 30" WITH RUBBER BAND UF (1) DRAPE CHEST 100" X 142" X 72" (1) RULER FLEXIBLE PLASTIC || (1) SOLUTION SURGICAL DURAPREP 26ML UF (1) SHEET :X 60" X 77" DRAPE REINFORCED UF || (1) STRIP STERI CLOSURE%'' X 4" UF (2) GOWN SOFT SMS STD. XL SET IN SLEEVE UF (4) NEEDLE HYPODERMIC 18G X 1 % U (1) SKIN MARKER W/RULER UF || (1) NEEDLE HYPODERMIC 25 X 1 % UF (1) DRESSING TELFA 8" X 3" NON ADH UF || (1) DRESSING TEGADERM 4 X 4%" UF (1) STERI-STRIP COMPOUND BENZOIN TINT 2/3cc VIALL /F (1) BAG ZIP LOCK UF (9) LABELS FOR SKIN MARKERS UF || Product Usage: || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.
Manufacturer
Customed, Inc

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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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