Devices

Device Recall Customed

Model / Serial
Product code 900-357, 2 lots: 113099550 113109831
Product Classification
Ophthalmic 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
OPHTALMIC PACK- (3) ABSORBENT TOWELS 15" X 20" LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) OPHTALMIC DRAPE WITH POUCH LIF || (2) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK LIF || (10) COTTON TIP APPLICATOR 6" WOOD || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (2) NEEDLE HYPODERMIC 18G X 1 Y." || (1) NEEDLE HYPODERMIC 25G X 5/8" || (2) EYE PAD 2 1/8 X 2 5/8 UF || (5) EYE SPEAR MICRO SPONGE || (2) LITE GLOVE LIF || (1) CABLE BIPOLAR || (1) EYE SHIELD UNIVERSAL || (1) OPHTALMIC PENCIL BIPOLAR || (1) IV ADM. SET 15 DROPS 106" LONG L/F || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) KNIFE/BLADE MIN. EDGE ROUND || (1) KNIFE 15 5.0 CONTROLLED || (1) PLASTIC TRAY 3/COMPARTMENT || (1)KNIFE 3.2MM ANGLE BEVEL UP || (1) CYSTOTOMO IRRIG. 25GA X5/8 || (1) MAYO TRAY LARGE || (2) GOWN STANDARD LARGE SMS STD VELCRO NECK || (1) PVP PAINT 8" STICK SPONGE || (1) NEEDLE & BLADE COUNTER 30c MAG/MAG/LF || 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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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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