Events

Recall of Device Recall RECEPTAL CANISTER

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Hospira 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
    66431
  • Event Risk Class
    Class 2
  • Event Number
    Z-0457-2014
  • Event Initiated Date
    2013-07-17
  • Event Date Posted
    2013-12-06
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-06
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122385
  • 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.
    ICU Medical, Inc. acquired from Pfizer in early 2017, Hospira Infusion Systems, the portion of Hospira dedicated to develop infusion pumps.
  • Extra notes in the data
    Apparatus, suction, operating-room, wall vacuum powered - Product Code GCX
  • Reason
    Hospira has recieved reports that the vacuum needed to create suction with the 1l receptal system cannot be achieved due to the canister and liner not properly seating.
  • Action
    An URGENT DEVICE RECALL letter dated July 17, 2013 was mailed to direct consignees. The letter requested the consignees: 1) quarantine any affected products, 2) complete and return the reply form included with the letter, 3) notify healthcare professionals within the consignee's organization of the recall, 4) return the affected products to Stericycle in accordance with the instructions in the letter. Consignees are further requested to forward a copy of the notification materials to any customers that they may have distributed the products to.

Device

Device Recall RECEPTAL CANISTER
  • Model / Serial
    *** DOMESTIC PRODUCT ***   List Numbers: 43449-04-11 and 43449-04-01;  Lot Numbers: All;   *** FOREIGN PRODUCT ***   List Numbers: 0L21297W1, 0L2129701, 0L2139701, 43449001L, 434490101, 434490102, 434490181, 434490181, 434490182, 4344901DX, 434496101, 434496161, 4344961A1, 434499090;  Lots: All
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including the states of AL, AZ, CA, CO, FL, GA, IL, IN, KS, MD, MI, MN, MO, MT, NC, ND, NE, NJ, NY, PA, SD, TX, UT, VA, and WA and countries of: Canada and EMEA.
  • Product Description
    Product is labeled in part: LIST NO. 43449; RECEPTAL CANISTER; DO NOT FILL 900 ABOVE THIS LINE; Product of China; Hospira, Inc.,; Lake Forest, IL 60045 USA. || Used to isolate suction waste during surgeries, or to clear patient airways, throat or wounds to allow treatment.
  • Manufacturer
    Hospira Inc.

Manufacturer

Hospira Inc.
  • Manufacturer Address
    Hospira Inc., 275 N Field Dr, Lake Forest IL 60045-2579
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    USFDA