Events

Recall of Rigid Suction Canister

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Medline Industries 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
    75128
  • Event Risk Class
    Class 2
  • Event Number
    Z-0352-2017
  • Event Initiated Date
    2016-08-10
  • Event Status
    Open, Classified
  • Event Country
    United States
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=149428
  • 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
    Bottle, collection, vacuum - Product Code KDQ
  • Reason
    Risk of implosion when the rigid suction canister is subjected to excessive negative pressure during use.
  • Action
    Medline Industries, Inc. sent an Urgent Recall Immediate Action Required letter dated August, 23, 2016, and destruction form via first class mail to affected customers on August 17, 2016 and August 23, 2016. The firm recommended the following actions: REQUIRED ACTION: 1. Immediately check your stock for item number OR220 and OR230 with lot numbers beginning with 9961601xxxx through 9961604xxxx (listed on the original case packaging). Destroy all affected products. If the rigid canisters are NOT in the original case packaging, we are instructing you to destroy them and we will send replacements. 2.Please return the completed enclosed destruction form listing the quantity of product(s) destroyed. Even if you do not have any of this product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will receive replacements. 3.If you are a distributor, promptly notify any of your customers that may have received affected product. If you have any questions, please contact 866-359-1704.

Device

Rigid Suction Canister
  • Model / Serial
    RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX and WA.
  • Product Description
    Rigid Suction Canister 3000 CC and 2000 CC.
  • Manufacturer
    Medline Industries Inc

Manufacturer

Medline Industries Inc
  • Manufacturer Address
    Medline Industries Inc, 1 Medline Pl, Mundelein IL 60060-4485
  • Manufacturer Parent Company (2017)
    Medline Industries Inc.
  • Source
    USFDA