Devices

Device Recall Customed

Model / Serial
Product code 900-2204, 5 lots 112050723 112062283 112083422 112093930 112125070
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 || CONTENTS: || ( I ) BULB SYRINGE 60cc LIF || ( I 0) GAUZE SPONGE 4" X 4" 1 6PLY XRD LIF || ( I ) MAYO STAND COYER REINFORCED LIF || ( I ) TABLE COVER REINFORCED 50" X 90" LIF || (3) GOWN SURG. REINFORCED XL EXTRA LONG LEVEL I V (4) TOWEL ABSORBENT I 5" X 20" LIF || ( I ) DRAPE VIDEO CAMERA I 3cm X 244cm LIF || (3) LITE G LOVE LIF || ( I ) DRAPE LAP ABDOM. WI POUCH 102" X 122" X 78" || ( I ) BLADE SURG ICA L # II STAIN LESS STEEL || ( I) SYRINGE I Occ W ITHOUT NEEDLE LUER LOCK LIF (4) DRAPE UTILITY WITH TAPE LIF || ( I ) SUTURE BAG FLORAL || (I) NEEDLE & BLADE COUNTER I OC MAG I C LEAR L/1' || ( I ) CABLE LAP. IOFR 4MM MALE MONOP. LIF || (2) DRESSING NON ADH TELfoA 4 X 3 || ( I ) SPECIMEN CONTAINER 4oz WITH LID & LABEL || (2) SH EET 'll.o 60" X 77" DRAPE R EI NFORCED LIF || ( I ) TUBING INSUFFLAT SET WIO RING ADAPTOR LIF || ( I ) CI-I LORAPREP 26ML APPLICATOR TEAL LIF || ( I ) WRAPPER 24" X 24" || (2) DENTURE CUP 8oz WILID || ADHERED OUTSIDE OF THE PACK INTO A POUCH: || ( I ) NEEDLE ULTRA VERES 1 20MM LIF || ( I ) TROCAR ENDO.XCEL DILATING TIP IIM M (D IILT) || ( I ) TROCA R ENDO.XCEL DILATING TIP LIF (K5LT) || ( I ) CANNU LA 5MM XCEL SLEEVES 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

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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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