Devices

Device Recall Customed

Model / Serial
Product code 900-1393, 6 lots: 112041420 113078354 113109651 140211586 140312499 140613718
Product Classification
Cardiovascular Devices
Device Class
1
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
OPEN HEART TRAY - - PACK A || ( 1) CV SPLIT DRAPE W/ CLEAR AN EST SCREEN STD SMS LIF || (5) DRAPE % ECONOMY 53" X 77" LIF || ( 1) MAYO STAND COVER REINFORCED LIF || (7) DRAPE UTILITY WITH TAPE L/F || (8) HUCK CLOTH TOWELS WHITE L/F || (20) HUCK CLOTH TOWELS BLUE LIF || (1) MAYO TRAY LARGE LIF || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE LIF || (6) 3/4 SHEET DRAPE REINFORCED LIF || (2) STOCKINETTE 9" X 48" LIF || (1) SPLIT SHEET BILATERAL 84" X 80" LIF || (3) DRAPE SHEET 41" X 58" SMS LIF || (4) Pr. GLOVES SURGEON #7 BIOGEL || OPEN HEART TRAY - HOSPITAL DAMAS - PACK B- || (1) PLASTIC RULER 12" LONG || (2) SYRINGE 60ML WITHOUT NEEDLE LISLIP L/F || (1) Pk. PEANUT SPONGE DISSECTOR ST. || (2) UTILITY BOWL 32 oz. LIF || (1) SKIN MARKER WITH RULER LIF || (2) UTILITY BOWL 16 oz. UF || (3) BULB SYRINGE 60cc UF || (1) MAYO TRAY SMALL L/F || (2) YANKAUER SUCT. TUBE WITHOUT VENT UF || (1) TRAY ORGANIZER FULL DEEP LIF || (5) SAPHENOUS VEIN CANNULA LIF || (40) LAP SPONGES PRE-WASH XRD UF || (2) ELASTIC BANDAGE 6" X 5 yds. UF || (2) SUTURE BAG FLORAL || (2) NEEDLE & BLADE COUNTER 40c FOAM/MAG UF || (1) BLADE SHARP ALL ARROUND 69 || (1) SURGICAL BLADE# 11 CARBON STEEL || (4) LITE GLOVES UF || (2) SURGICAL BLADE# 15 CARBON STEEL || (1) SPECIMEN CONTAINER 4oz. WITH LID & LABEL || (1) SYRINGE 1 cc TUBER 25G X 5/8 S/TIP LIF || (2) POUCH INSTRUMENT || (2) SURGICAL BLADE# 10 CARBON STEEL || (30) GAUZE SPONGES 4" X 4" 16 PLY XRD UF || (2) CAUTERY PENCIL ROCKER SWITCH LIF || (2) POLISHER CAUTERY TIP UF || (1) LABEL SET, HEPARINE,SALINE || (2) ELASTIC BANDAGE 4" X 5 yds. LIF || (1) TABLE COVER BTC 77" X 110" HD FULL COVERAGE UF (1) NEEDLE HYPODERMIC 18G X 1% LIF || (2) COTION GLOVE HEAVY DUTY || (1) AORTIC MONITORING PRESS SET 5.0 || (1) CONNECTOR Y 3/8" X 3/8" X 3/8" LIF || (2) NEEDLE HYPODERMIC 22G X 1 % LIF || (1) BLADE 6.1 X 32.3 X 1.0MM || (1) SQUARE TWO PIECE 500cc GRADUATE || (2) CONNECTOR REDUCER || (1) NEEDLE BLADE/KNIFE 3.0MM || 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

326 more

About this database

Explore more than 120,000 Recalls, Safety Alerts and Field Safety Notices of medical devices and their connections with their manufacturers.

Stories in your inbox

Do you work in the medical industry? Or have experience with a medical device? Our reporting is not done yet. We want to hear from you.

Tell us your story!

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.

Download the data

The International Medical Devices Database is licensed under the Open Database License and its contents under Creative Commons Attribution-ShareAlike license. Always cite the International Consortium of Investigative Journalists when using this data. You can download a raw copy of the database here.

Download all (zipped)