Devices

Device Recall Customed

Model / Serial
Code 900-2903, 4 lots 113026303 113057705 113068034 113088858
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
ORTHOPEDIC IMPLANT || PACK CUSTOMED USA, CODE 900-2903 || CONTENTS: || (1) CAUTERY TIP POLISHER UF || (1) SKIN MARKER W/RULER || (1) BAG SUTURE FLORAL || (1) U - DRAPE 60" X 70" WITAPE SPLIT 6" X 21" || (1) TUBE SUCTION CONNECT W' X 12' UF || (2) PAD ABDOMINAL 8" X 7.5" || (1) BAG GLASSINE || (1) YANKAUER SUCTION TUBE W/0 VENT LIF || (2) LITE GLOVE UF || (1) SOLUTION SURGICAL DURAPREP 26ML LIF || (2) TABLE COVER REINFORCED 50" X 90" LIF || (1) BLADE SURGICAL# 10 STAINLESS STEEL || (1) MAYO STAND COVER REINFORCED LIF || (1) SHEET SPLIT W/ADHES 108" X 77" STD SMS L/F || (5) TOWELS ABSORBENT 15" X 20" UF || (1) STOKINETIE IMPERVIOUS 14" X 48" LIF || (2) DRAPE SHEET 70" X 100" LIF || (1) *GLOVE# 7'!h SURGEON NEUTRALON LATEX || (5) LAP SPONGE PREWASH 18" X 18" XRD LIF || (1) *GLOVE # 8 SURGEON NEUTRALON LATEX || (1) SKIN STAPLE 35 WIDE UF || (1) *GLOVE# 8'!h SURGEON NEUTRALON LATEX || (1) TRAY MAYO LGE || (1) GOWN SURG REINFORCED XL TOWEUWRAP || (1) DRAPE TOP W/ADHES 108" X 50" STD SMS UF || (2) GOWN XL SMS IMPERVIOUS REINFORCED UF || (1) BULB SYRINGE 60cc CLEAR || (1) CAUTERY PENCYL ROCKER SWITCH UF || (1) UTILITY BOWL 16oz LIF || (1) BLADE SURGICAL# 20 STAINLESS STEEL || (1) UTILITY BOWL QUART 32oz LIF || (4) DRAPE UTILITY WITAPE UF || (1) DRAPE INCISION 23" X 17" UF || Product Usage: || 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

Learn more about the data here

Device Recall Customed

Model / Serial
LOTS: SL15197 (150719633) 31-JUL-16 SL15201-01 (150719633)31-JUL-16 SL15201-02 (150719632)31-JUL-16 SL15203 (150719632) 31-JUL-16 SL15240 (150720068) 31-AUG-16 SL15240 (150820069) 31-AUG-16 SL15243 (150820069) 31-AUG-16
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed only in Puerto Rico.
Product Description
Catalog Number: 9001296 || PREMIUM LAPAROTOMY PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
LOTS: SL15210 (150719663) 31-JUL-16 SL15244 (150820222) 31-AUG-16
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed only in Puerto Rico.
Product Description
Catalog Number: 900169 || UNIVERSAL SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
LOT: SL15209 (150719960) 31-JUL-16
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed only in Puerto Rico.
Product Description
Catalog Number: 9001738 || UROLOGY SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
LOTS: SV15168 (141015851) 31-OCT-15 SL15187 (150619088) 30-JUN-16 SL15187 (150719604) 31-JUL-16 SL15191-01 (150719604) 31-JUL-16 SL15261 (150920134) 30-SEP-16 SL15264 (150920725) 30-SEP-16 SL15264 (150920134) 30-SEP-16
Product Classification
General and Plastic Surgery Devices
Device Class
1
Implanted device?
No
Distribution
Distributed only in Puerto Rico.
Product Description
Catalog Number: 900010 SUTURE REMOVAL KIT || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
Catalog Number: 900012 LOTS: SL15202 (150719606) 31-JUL-16 SL15210 (150720034) 31-JUL-16 SL15219 (150720056) 31-JUL-16
Product Classification
Obstetrical and Gynecological Devices
Device Class
2
Implanted device?
No
Distribution
Distributed only in Puerto Rico.
Product Description
Catalog Number: 900012 OB SURGICAL PACK || Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
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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