Events

Safety Alert for Receptal System Liners and Canisters

According to Department of Health, this safety alert involved a device in Hong Kong that was produced by Hospira Inc.

What is this?

Alerts provide important information and recommendations about products. Even though an alert has been issued, it does not necessarily mean a product is considered to be unsafe. Safety Alerts, addressed to health workers and users, may include recalls. They can be written by manufacturers, but also by health officials.

Learn more about the data here
  • Type of Event
    Safety alert
  • Date
    2013-09-17
  • Event Date Posted
    2013-09-17
  • Event Country
    Hong Kong
  • Event Source
    DH
  • Event Source URL
    https://www.mdco.gov.hk/english/safety/recalls/recalls_20130917a.html
  • Notes / Alerts
    Hong Kong data is current through September 2018. All of the data comes from the Department of Health (Hong Kong), except for the categories Manufacturer Parent Company and Product Classification.
    The Parent Company and the Product Classification were added by ICIJ.
    The parent company information is based on 2017 public records. The device classification information comes from FDA’s Product Classification by Review Panel, based on matches of data from the U.S. and Hong Kong.
    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
    Medical Device Safety Alert
  • Reason
    Medical device safety alert: hospira receptal system liners and canisters the medicines and healthcare products regulatory agency (mhra), united kingdom (uk) posted a medical device safety alert concerning receptal system liners and canisters manufactured by hospira inc. hospira has become aware that customers may be inappropriately using incorrectly sized receptal liners with receptal canisters (e.G. 1.5l liner, 2l liner or 3l liner with a 1l canister). to date, hospira has received reports associated with this practice, including one case resulted in serious injury and one case resulted in death. hospira explains that the lid may not fit and the suction will not be sufficient and/or consistent if incorrectly sized liners are used. if suction is compromised during a general surgical procedure, the fluids may impair the surgeon’s vision and ability to expeditiously complete the procedure. the harm includes progression of the untreated condition that may result in symptoms such as hypertension, tachycardia, and bradycardia. furthermore, the delay may result in a prolonged exposure to any anaesthesia used during the procedure. compromised suction leads to diminished efficacy of the product and/or delay in therapy, both of which can result in life threatening situations if airway clearance or gastric suction is needed. therefore, hospira recommends that hospira/abbott canisters should only be used with appropriately sized hospira/abbott receptal lid/ liners. hospira recommends the users to follow the receptal set up instructions which reminds the users to fully extend and insert the liner. in addition, hospira will update the instructions for use to reflect the appropriate use of the affected products. for instance, a 1l liner should be matched with a 1l canister and hospira/abbott liners should be matched with hospira/abbott canister. for details, please visit the following mhra website: http://www.Mhra.Gov.Uk/safetyinformation/safetywarningsalertsandrecalls/fieldsafetynotices/con314890 if you are in possession of the affected products, please contact your supplier for necessary actions. posted on 17 september 2013.

Device

Receptal System Liners and Canisters
  • Model / Serial
  • Product Description
    Medical Device Safety Alert: Hospira Receptal System Liners and Canisters
  • Manufacturer
    Hospira Inc

Manufacturer

Hospira Inc
  • Manufacturer Parent Company (2017)
    Pfizer
  • Source
    DH