Devices

Device Recall Customed

Model / Serial
900-3178, 4 lots: 131210899 140211837 140312152 140513143
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 pack, , Code 900-3178, contains: || (1) BULB SYRINGE 60cc LIF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD LIF || (1) MAYO STAND COVER REINFORCED LIF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (3) GOWN SURG REINFORCED XL EXTRA LONG LEVEL IV || (4) TOWEL ABSORBENT 15" X 20" LIF || (1) DRAPE VIDEO CAMERA 13cm X 244cm LIF || (3) LITE GLOVE LIF || (1) DRAPE LAP ABDOMINAL W/POUCH 102" X 122" X 78" || (1) BLADE SURGICAL# 11 || (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK LIF || (4) DRAPE UTILITY WITH TAPE LIF || (1) SUTURE BAG FLORAL L/F || (1) NEEDLE & BLADE COUNTER 10c MAG/CLEAR LIF || (1) CABLE LAP 10FR 4MM MALE MONOP. LIF || (1) SPECIMEN CONTAINER 4oz W/LID & LABEL || (2) SHEET% 60" X 77" DRAPE REINFORCED LIF || (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR LIF || (1) WRAPPER 24" X 24" LIF || (1) ULTRA VERES NEEDLE 120MM LIF || (1) TROCAR ENDO.XCELL DILATING TIP 11 MM || (1) TROCAR ENDO.XCELL DILATING TIP 5MM LIF || (1) CANNULA 5MM XCEL SLEEVES LIF || (2) DENTURE CUP 8oz W/LID || (2) DRESSING NON ADH TELFA 4" X 3" || (1) CHLORAPREP 26ML APPLICATOR TEAL LIF || 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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