Events

Recall of Receptal Liners

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
    66448
  • Event Risk Class
    Class 2
  • Event Number
    Z-2594-2016
  • Event Initiated Date
    2013-09-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-15
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127262
  • 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 become aware of customers using the incorrect size receptal liners with their receptal canisters, e.G., 1.5 l liner, 2l liner or 3l liner with a 1l canister. it is possible that if an incorrectly sized liner is used with a different size canister the lid may not fit and the vacuum/suction will not be sufficient and/or consistent.
  • Action
    URGENT MEDICAL DEVICE RECALL letters dated September 10, 2013 were distributed to direct accounts notifying them of the recall. The letter requests that customers to ensure that they only use liners and canisters of corresponding sizes (e.g. a 1000mL liner with a 1000mL canister) and to only use Hospira components. The letter further advises customers of an ongoing recall of the 1000mL Receptal systems. Customers were requested to complete and return the attached reply form and to notify other healthcare providers within their organization.Customers who further distributed the Receptal systems were requested to forward the letter to their customers and to request that the contact Stericycle at 1-888-943-5175 (Monday - Friday, 8:00 AM - 5:00 PM, CST) to obtain a reply form.

Device

Receptal Liners
  • Model / Serial
    43001-04-01 43023-04-01 43024-04-01 43024-04-62 43025-04-01 43025-04-11 43025-04-21 43025-04-25 43027-04-01 43027-04-05 43027-04-11 43027-04-14 43027-04-17 43031-04-02 43032-04-05 43034-04-06 43036-04-04 43037-04-02 43038-04-04 43038-04-05 43041-04-01 43042-04-01 43042-04-11 43043-04-01 43044-04-01 43044-04-05 43044-04-11 43044-04-15 43044-04-51 43046-04-01 43046-04-05 43047-04-01 43056-04-01 43061-04-01 43062-04-01 43063-04-01 43064-04-01 0L212-01 0L213-01
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    *** US: Nationwide (AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY), District of Columbia, Puerto Rico; *** FOREIGN: Australia, Canada, Costa Rica, Singapore, South Africa
  • Product Description
    Hospira RECEPTAL LINERS: 1L(1000mL), 1.5L (1500mL), 2L (2000mL) || 1) List Number 43056-01; || 2) List Number 43023-01; || 3) List Number 43025-01; || 4) List Number 43025-11; || 5) List Number 43025-21; || 6) List Number 43025-25; || 7) List Number 43038-05; || 8) List Number 43043-01; || 9) List Number 43044-01; || 10) List Number 43044-11; || 11) List Number 43046-01; || 12) List Number 43047-01; || 13) List Number 43041-01; || 14) List Number 43024-01; || 15) List Number 43027-01; || 16) List Number 43027-14; || 17) List Number 43001-01; || 18) List Number 43064-01; || 19) List Number 43046-05; || 20) List Number 43042-11; || 21) List Number 43042-01; || 22) List Number 43044-05; || 23) List Number 43044-15
  • 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