Events

Recall of Device Recall Customed

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Customed, Inc.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68536
  • Event Risk Class
    Class 1
  • Event Number
    Z-2320-2014
  • Event Initiated Date
    2014-05-20
  • Event Date Posted
    2014-08-29
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-14
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129158
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Cesarean section kit - Product Code OHM
  • Reason
    Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). this could result in an injury to the patient due to product contamination or loss of sterility condition.
  • Action
    Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Device

Device Recall Customed
  • Model / Serial
    Product code 900-403, 30 lots: 112020525 112030955 112031372 112051682 112062486 112093590 112104107 112125170 112125315 113015449 113015695 113025960 113036485 113046957 113057479 113057817 113068169 113078573 113088813 113099289 113099571 131110076 131110409 131110586 131210970 140211667 140311937 140312382 140412836 140513246
  • 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
    CESAREAN PACK - - || (7) TOWELS ABSORBENT 15" X 20" || (2) SCALPEL WEIGHTED SAFETY #1 0 || (1) BLANKET BABY 30" X 30" POLY ABS IMP || (1) BOWL UTILITY QUART 32oz. || (1) TUBE FEEDING 8Fr. 15" LONG || (2) COUNTER NEEDLE/BLADE 10C MAG/CLEAR || (1) BEANNIES BABY || (2) PAD OBSTRETICAL XLGE ST. || (1) SYRINGE 20cc W/0 NEEDLE LIL || (1) SYRINGE EAR/ULCER 2oz. || (1) BLANKET RECEIVING 100% COTION || (1) CLAMP UMBILICAL CORD ST. || (1) COVER TABLE REINFORCED 50" X 90" || (1) SYRINGE 10CC W/0 NEEDLE L/LOCK || (1) BOWL PLASTIC W/LID 80oz || (2) GOWN XL SMS IMPERVIOUS REINFORCED || (1) SHEET DRAPE 41" X 58" SMS || (1) DRAPE C SECTION W/POUCH 102" X 121" X 78" || (1) YANKAUER SUCTION TUBE W/0 VENT || (1) WRAPPER 30" X 30" || (15) SPONGE LAP PREWASH 18" X 18" XRD || (1) TIME OUT BEACON NON WOVEN ST. || (1) TUBE SUCTION CO NN ECT~" X 12' || (2) LIGHT SHIELD || (1) GOWN SURG REINF LARGE T/WRAP || (2) PK. STRIP STERI CLOSURE W' X 4" || (1) POLISHER CAUTERY TIP || (1) DRESSING COMP OP 4" X 14" || (1) COVER MAYO STAND REINFORCED || (1) SKIN MARKER INK W/8 LABEL/TIME OUT/RULER || EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
  • Manufacturer
    Customed, Inc

Manufacturer

Customed, Inc
  • Manufacturer Address
    Customed, Inc, Calle Igualdad Final #7, Fajardo PR 00738
  • Manufacturer Parent Company (2017)
    Customed Inc
  • Source
    USFDA