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-2442-2014
  • 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=129400
  • 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
    Ear, nose, and throat surgical tray (kit) - Product Code OGR
  • 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 900-2234, 8 lots 112030726 113088792 113109792 131110112 131110338 140211660 140412835 140512993
  • Product Classification
    Ear, Nose, and Throat 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
    EAR PACK || CONTENTS: || ( I ) B LADE SU RG ICA L # 15 CARBON STEEL || ( I ) EMESI S BASIN lO in 700cc || ( I ) GOWN XL SMS IM P. REINFORCED || ( I ) NEEDLE HYPODERM IC 1 8G X I 'h || ( I ) WASH BASIN ROUND 6QT || ( I ) INSTRUMENT POUCH 7 X II 2COMPARTMENT || (I) STERI STR I P CLOSURE 'h" X 4" || ( I) SYRINGE 3cc WITHOUT NEEDLE LILOCK || (2) SYRINGE I ML WITHOUT NEEDLE LILOCK || (I) CAUTERY TIP POLISHER || (I) SHEET ENT SPLIT 110" X 77" SMS || ( I ) GOWN I MP XTRA REINF. SMS XLT/ W LEVEL I V || (2) LITE GLOVE || (1 2) TOWELS CLOTH HUCK (BLUE) || ( I ) TUBE SUCTION CONNECT W' X 1 2' || (I) EAR ULCER SYRINGE 2oz || (I) TABLE COYER REINFORCED 50" X 90" || ( I) UTILITY BOWL 16oz || (4) APPLICATOR COTTON 6" WOOD || (2) STRJPS TAPE 24" X 4" || ( I ) GOWN LGE SMS I MPERVIOUS REINFORCED ( I ) WIPE INSTRUMENT LMM 8.25 X 8.25 || ( I ) MAYO STAND COYER REINFORCED || ( I ) NEEDLE & BLADE COUNTER 20c FOAM/ MAG ( I ) SYRINGE I Occ WITHOUT NEEDLE LILOCK || ( I ) MAYOTRAY SMALL || ( I ) SYRINGE I Occ TI P CONTROL LUER LOCK ( I ) DRAPE M ICROCOSPE LE I CA 42 X 105 || ( I ) TI ME OUT BEACON NON WOVEN || (I) BLADE M IN IATURE CARBON STEEL || (10) GAUZE SPONGE 4" X 4" 1 6PLY XRD || (I) SK I N MARKER INK W/8 LABEL || (2) NEEDLE HYPODERM I C 27G X I W' || ONE PACK WET SK IN W ITH CONTENTS: || ( I ) WRAPPER SMS 30" X 30" || (2) COTTON TIP APPLICATOR 6" WOOD || (2) GLOVE MED FREETOUCH VYNIL P/F || (6) SPONGE W ING SMALL || (4) TOWELS ABSORBENT 1 5" X 20" || (3) TIP ABSORB. APPLICATOR STI CK SPONGE || ( I ) PVP IODOPHOR PAINT 4oz. BOTTLE || (I) PVP SCRUB SOLUTION 4oz. BOTTLE || (I) TRAY 3/COMPARTMENT || Product Usage: || 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