Devices

Device Recall Customed

Model / Serial
Product code 900-635, 42 lots: 110040968 110051274 110051406 110092404 110112815 110112897 111020476 111030646 111041113 111051299 111061558 111071830 111082247 111092399 111102773 111112950 111123278 112020492 112041343 112083439 112093730 112125105 112125304 113015514 113036673 113036736 113047027 113057609 113067934 113068178 113088881 113099448 113109866 113507497 131110310 131210835 140111242 140211675 140211944 140312385 140412840 140513250
Product Classification
Obstetrical and Gynecological 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
PERY GYN PACK- || (1) DRAPE UTILITY WITH TAPE UF || (1) UNDERBUTTOCK DRAPE WITH POUCH || (2) ABSORBENT TOWELS 15" x 20" UF || (2) LEGGINS W/7'' CUFF 30" X 42" || (1) TABLE COVER REINFORCED 50" X 90" UF || (1) ABDOMINAL DRAPE WITH TAPE UF || (1) UTILITY BOWL 16oz. || (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD UF || (1) PAD OBSTETRICAL XL LIF || (2) SPECIMEN CONTAINER 4oz. W/LID & LABEL || (1 ) SYRINGE 1 Occ PREFILLED W/GEL || (1 ) DRAPE SHEET 41 " X 69" MEDIUM UF || (1 ) CATHETER 14FR. ROB. NELAT || (1) NON-ADHESIVE TELFA DRESSING || (2) GOWN IMP. REINFORCED LGE SMS || 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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