Customed, Inc

FDA Regulatory Profile

Summary

Total Recalls
682 (412 Class I)
510(k) Clearances
36
Inspections
9
Compliance Actions
2

Recent Recalls

NumberClassProductDate
Z-1436-2016Class IICatalog Number: 9001765 MINOR LACERATION TRAY Used by medical staff to perform surgical procedureJanuary 7, 2016
Z-1442-2016Class IICatalog Number: 9002164 FEMORAL SURGICAL PACK Used by medical staff to perform surgical procedureJanuary 7, 2016
Z-1443-2016Class IICatalog Number: 9002167 LITHOTOMY SURGICAL PACK Used by medical staff to perform surgical procedJanuary 7, 2016
Z-1446-2016Class IICatalog Number: 9002256 NEUROSURGERY PACK Used by medical staff to perform surgical procedures aJanuary 7, 2016
Z-1457-2016Class IICatalog Number: 9002766 SHOULDER PACK Used by medical staff to perform surgical procedures and pJanuary 7, 2016
Z-1422-2016Class IICatalog Number: 9001402 PLASTIC SURGERY PACK Used by medical staff to perform surgical proceduresJanuary 7, 2016
Z-1461-2016Class IICatalog Number: 9002829 BASIC SURG PACK Used by medical staff to perform surgical procedures andJanuary 7, 2016
Z-1488-2016Class IICatalog Number: 900782 SKIN STAPLE REMOVER STERILE Used by medical staff to perform surgical procJanuary 7, 2016
Z-1397-2016Class IICatalog Number: 9001771 MAYO STAND COVER STERILE Used by medical staff to perform surgical proceduJanuary 7, 2016
Z-1417-2016Class IICatalog Number: 9001294 PREMIUM CESAREAN PACK Used by medical staff to perform surgical procedureJanuary 7, 2016
Z-1441-2016Class IICatalog Number: 9002123 KNEE ARTHROSCOPY SURGICAL PACK Used by medical staff to perform surgicalJanuary 7, 2016
Z-1407-2016Class IICatalog Number: 900080 CYSTOSCOPY SURGICAL PACK Used by medical staff to perform surgical procedurJanuary 7, 2016
Z-1491-2016Class IICatalog Number: 900944 CATARACT SURGICAL PACK Used by medical staff to perform surgical procedurJanuary 7, 2016
Z-1405-2016Class IICatalog Number: 900063 WOUND CLOSURE TRAY I Used by medical staff to perform surgical procedures aJanuary 7, 2016
Z-1440-2016Class IICatalog Number: 9001966 LIVER & PANCREAS SURGERY Used by medical staff to perform surgical proceJanuary 7, 2016
Z-1478-2016Class IICatalog Number: 900548A PERY-GYN SURGICAL PACK Used by medical staff to perform surgical procedurJanuary 7, 2016
Z-1449-2016Class IICatalog Number: 9002510 UROLOGY SURGICAL PACK Used by medical staff to perform surgical procedurJanuary 7, 2016
Z-1475-2016Class IICatalog Number: 900522 SURGICAL GOWN SMS POLY-REINFORCED, RAGLAN SLEEVE, AAMI LEVEL III, LARGE UsJanuary 7, 2016
Z-1415-2016Class IICatalog Number: 9001198 WOUND MANAGE II Used by medical staff to perform surgical procedures and January 7, 2016
Z-1483-2016Class IICatalog Number: 900633 FAN FOLD SHEET 44 X 58 Used by medical staff to perform surgical procedureJanuary 7, 2016

Recent 510(k) Clearances

K-NumberDeviceDate
K974647FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633January 5, 1998
K971920GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522)December 4, 1997
K964011SUCTION CATHETER TRAY PRODUCT NO. 900277November 25, 1996
K962652URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749)October 4, 1996
K962596CUSTOMED BLOOD EXTRACTION KITSeptember 27, 1996
K961442UNIVERSAL DRAINAGE TRAYMay 9, 1996
K953678STERIMED STERIZATION WRAPPER (NON-STERILE)October 2, 1995
K950295WOUND CLOSURE/LACERATION TRAYApril 18, 1995
K942177FOLEY CATHETERIZATION TRAYSeptember 8, 1994
K925018IV PREP KIT W/O DRESSING (NON-STERILE)August 27, 1993
K925017IV PREP KIT (NON-STERILE)August 27, 1993
K930986BLOOD GAS KIT (NON-STERILE) REORDER NO. 0560July 14, 1993
K925020TRACHEOSTOMY CARE KIT (STERILE)July 7, 1993
K925015STERILE SUTURE REMOVAL KITJune 7, 1993
K925021TPN TRAY (STERILE)June 7, 1993
K924809IRRIGATION TRAY W/ BULB SYRINGEJune 7, 1993
K925016PREP SHAVE KIT (NON-STERILE)April 26, 1993
K925022SURGICAL TRAY (STERILE)April 26, 1993
K904694CUSTOMED ANGIODRAPE PACK FEMORALJanuary 2, 1991
K904693CUSTOMED CARDIOVASCULAR PACKJanuary 2, 1991