Recall: Cook Medical Fixed Core & Roadrunner Hydrophilic Wire Guides – compromised sterility

A recall has been issued for wire guide products from Cook Medical with the following lot numbers:

• Australia:
  • Fixed Core Wire Guide, lot numbers: 14821853, 14833106, 14811925, NS14795068.
  • Roadrunner Hydrophilic Wire Guide, lot number: NS14828650.
• New Zealand:
  • Cook Medical TFE Wire Guide, lot number: 14821855.

The packaging of these device lot numbers has a complete breach in the chevron seal, meaning that sterility is compromised. The devices may be non-sterile or contaminated with microorganisms, and could cause infection in patients if used.

The distributor advises customers to quarantine and return any unused affected stock.
For more information, see the Therapeutic Goods Administration Australia recall listing or the Medsafe New Zealand recall listing.