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-2313-2014
  • 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=129146
  • 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
    Angiography/angioplasty kit - Product Code OEQ
  • 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 900-210, 30 lots: 112030717 112041290 112041446 112051934 112072622 112093725 112114388 112114598 113015442 113015630 113036436 113036760 113047216 113057458 113057699 113057816 113068045 113068165 113078572 113089023 113099285 113109786 131110235 131110605 131210967 140111414 140211876 140312332 140412833 140513348
  • Product Classification
    Cardiovascular 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
    ANGIOGRAPHY PACK- - || (4) CLOTH HUCK TOWEL BLUE UF || (1) TABLE COVER REINFORCED 50" X 90" LIF || (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF || (2) MEDICINE CUP 2oz. LIF || (3) UTILITY BOWL 32oz UF || (1) EMESIS BASIN 10 IN 700cc || (4) TOWEL CLAMP || (3) ABSORBENT TOWELS 15" X 20" LIF || (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F || (1) HALSTED MOSQUITO || (1) PVP SCRUB 8" STICK SPONGE || (1) TRAY PLATFORM LARGE || (3) LABELS FOR SKIN MARKERR || (1) LABEL FOR MEDICATION SALINE NORMAL BLUE || (1) LABEL FOR MEDICATION TRIDIL VIOLETA || (1) NEEDLE HYPODERMIC 18G X 1 'h || (4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF || (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF || (2) UTILITY BOWL 16oz || (3) BAND BAG WITH RUBBAND & TAPE LIF || (25) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF || (1) DRAPE ANGlO 75" X 145" || (1) NEEDLE HYPODERMIC 21 G X 1 'h LIF || (1) SAFETY SCALPEL #11 LIF || (1) GOWN STANDARD SMS LARGE VELCRO NECK || (2) NEEDLE HYPODERMIC 23G X 1" || (1) TRAY ORGANIZER FULL DEEP || (1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP || (1) LABEL XYLOCAINE FOR MEDICATION YELLOW || (1) LABEL CONTRASTE FOR MEDICATION GREEN || (1) LABEL FOR MEDICATION INTEGRILIN RED || (1) PVP PAINT 8" STICK SPONGE || 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