Events

Recall of JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS

According to Health Canada (via FOI), this recall involved a device in Canada that was produced by CARDINAL HEALTH CANADA 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
    52558
  • Event Risk Class
    II
  • Event Initiated Date
    2017-04-27
  • Event Country
    Canada
  • Event Source
    HC
  • Notes / Alerts
    Canadian data is current through March 2018. All of the data comes from Health Canada, 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 recall data from the U.S. and Canada.
  • Extra notes in the data
  • Reason
    Cardinal health has become aware of a potential breach of sterility in the packaging of certain jackson-pratt perforated and hemaduct wound drainage systems. in a small percentage of product (approximately 1.6%) the inner packaging (polybag) is caught in the seal area of the outer tyvek pouch potentially compromising the sterility of the package contents. while sterility is only impacted if the polybag fully breaches the seal (approximately 0.23% of product) as a precautionary measure cardinal health is taking this action to ensure that product is not used if any portion of the polybag is caught in the seal area. use of impacted products could result in an increased risk of infection.

Device

JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS
  • Model / Serial
    Model Catalog: SU130-1309 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1308 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUF100 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1310 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1410 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1411 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1311 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1323 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1321 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-1320 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0323 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0321 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: SU130-0521 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR190 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR151 (Lot serial: > 100 NUMBERS CONTACT MFG); Model Catalog: JP-HUR
  • Product Description
    JACKSON-PRATT SILICONE FLAT DRAINS W/WO TROCARS;JACKSON-PRATT SILICONE ROUND DRAINS W/WO TROCARS;JACKSON-PRATT PVC ROUND DRAINS WITH ATTACHED TROCAR
  • Manufacturer
    CARDINAL HEALTH CANADA INC.

Manufacturer

CARDINAL HEALTH CANADA INC.
  • Manufacturer Address
    MISSISSAUGA
  • Manufacturer Parent Company (2017)
    Cardinal Health
  • Source
    HC