Devices

Device Recall Customed

Model / Serial
Product code 900-1803, 7 lots: 112114857 112125169 113026230 113036759 140312276 140412556 140513115
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 PREMIUM PACK - || (1) TABLE COVER REINFORCED 50" x 90" UF || (4) TOWEL ABSORBENT 15" x 20" UF || (10) GAUZE SPONGE 4" X 4" 16PLY XRD UF || (1) DRAPE LASER CAMERA W/EL UF || (1) TROCAR ENDO.XCEL DILATING TIP (KSLT) || (1) APPLIER CLIP 5MM || (3) GOWN XLGE SMS IMPERV. REINFORCED || (1) BLADE SURGICAL #11 S/STEEL || (1) NEEDLE PNEUMO INSUFLAT. 150MM UL UF || (1) MAYO STAND COVER REINFORCED UF || (1) DRAPE LAPAROSCOPY ABDOM. W/POUCH || (4) DRAPE UTILITY WITH TAPE UF || (1) TUBING INSUFFLATION SET W/0 RING ADAPTOR U/F || (1) TROCAR DILATING XCEL 5MM x 100 (D5LT) || (1) TROCAR ENDO.XCEL DILATING TIP 11MM || (1) SUTURE BAG FLORAL UF || (1) CLOSURE SKIN W' X 4" STERI STRIP 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: 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

Device Recall Customed

Model / Serial
LOTS: SL15180 (150619409) 31-MAY-16 SL15181 (150619409) 31-MAY-16 SL15197 (150719607) 31-MAY-16 SL15201-01 (150719607) 31-MAY-16 SL15230 (150820136) 31-AUG-16 SL15251 (150820136) 31-AUG-16 SL15265 (150920652) 30-SEP-16 SL15266 (150920652) 30-SEP-16
Product Classification
General Hospital and Personal Use Devices
Device Class
1
Implanted device?
No
Distribution
Distributed only in Puerto Rico.
Product Description
Catalog Number: 900020 IRRIGATION TRAY WITH IRRIGATION BULB SYRINGE || 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: SL15194 (150719926) 31-JUL-16 SL15194 (150719927) 31-JUL-16 SL15195-02 (150719927) 31-JUL-16 SL15195-02 (150719926) 31-JUL-16 SL15258 (150719926) 31-JUL-16 SL15258 (150719927) 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: 900028 LAPAROSCOPY SURGICAL PACK
Manufacturer
Customed, Inc

Device Recall Customed

Model / Serial
LOTS: SL15173 (150619057) 30-JUN-16 SL15174 (150619057) 30-JUN-16 SL15175 (150619057) 30-JUN-16 SL15209 (150719928) 31-JUL-16 SL15210 (150719928) 31-JUL-16 SL15216 (150719928) 31-JUL-16 SL15224 (150820057) 31-AUG-16 SL15229 (150820057) 31-AUG-16 SL15258 (150920726) 30-SEP-16 SL15259 (150920726) 30-SEP-16 SL15260 (150920726) 30-SEP-16
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed only in Puerto Rico.
Product Description
Catalog Number: 900032 UNIVERSAL DRAINAGE TRAY || 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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