Events

Recall of Device Recall Various custom surgical kits

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Custom Assemblies 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
    77962
  • Event Risk Class
    Class 2
  • Event Number
    Z-3059-2017
  • Event Initiated Date
    2017-06-15
  • Event Date Posted
    2017-08-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-08-28
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=158352
  • 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
    General surgery tray - Product Code LRO
  • Reason
    The firm manufactured and distributed custom surgical kits which contained bd safetyglide" 22ga 1¿ inch needles. bd subsequently recalled these needles because, " loose polypropylene particulate in the fluid path could be expelled out of the needle during injection.
  • Action
    BD sent an Urgent Medical Device Recall letter dated June 12, 2017, to all affected consignees. Consignees were instructed to examine their inventory and quarantine any affected product. Consignees with questions should call 201-847-4267. For questions regarding this recall call 919-202-8462.

Device

Device Recall Various custom surgical kits
  • Model / Serial
    (a) Lot Numbers: 42754-1603, 42798-1603, 43030-1604  (b) Lot Numbers: 42696-1602, 43200-1604, 433322-1605  (c) Lot Numbers: 43056-1604,  (d) Lot Numbers: 42836-1603, 43182-1604  (e) Lot Numbers: 42794-1603  (f) Lot Numbers: 42912-1603 (g) Lot Numbers: 43416-1606 (h) Lot Numbers: 43414-1606
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide Distribution to NJ, TN, NY, KS, OH, CA,
  • Product Description
    Various custom surgical kits manufactured for CMS, CUSTOM MEDICAL SPECIALTIES, INC.: || (a) CMS-4153-R2 MPM Biopsy TRAY || (b) CMS-5832-R1 Custom Safety Mammo Biopsy Tray || (c) CMS-4108 Multipurpose Safety Tray || (d) CMS-3141-R6 Custom Ultrasound Tray || (e) CMS-2891-R1 Custom Safety Biopsy Tray || (f) CMS-5798-R1 Custom Safety Biopsy Tray || (g) CMS-2357R2 Custom Biopsy Tray || (h) CMS-2540-R4 Custom Biopsy Tray
  • Manufacturer
    Custom Assemblies Inc

Manufacturer

Custom Assemblies Inc
  • Manufacturer Address
    Custom Assemblies Inc, 330 E. Main Street, Pine Level NC 27568
  • Manufacturer Parent Company (2017)
    Custom Assemblies Inc.
  • Source
    USFDA