The Recall Desk
HighFDA (Devices)·Z-1843-2022·Announced 2022-10-05

Torq-Flex Wire Guide Guidewires Recalled Due to Packaging Seal Defect

Cook Incorporated is recalling Torq-Flex Wire Guide guidewires because the packaging chevron seal may be breached, potentially compromising device sterility. The affected units were distributed domestically and internationally.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II sterile medical device with complete packaging seal breach potentially compromising sterility. Meets High severity threshold as a risk-of-harm product where injury has not been reported.

Plain-English summary

Cook Incorporated is recalling Torq-Flex Wire Guide Australian Modification guidewires (part number STF-18-40-AUST, UDI-DI 00827002073043) because affected units from specific production lots may have a complete breach of the chevron seal of the packaging. This breach may compromise the sterility of the devices.

The recall affects 149 units distributed domestically throughout the United States and internationally. A breach in the packaging seal creates a risk that contaminants could compromise device sterility.

Affected lot numbers are 14788615, 14816230, and 14836977. Healthcare providers and patients using affected devices should contact Cook Incorporated for guidance regarding device replacement and handling procedures.

The recalled product

Product
Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Number/GPN STF-18-40-AUST G07304
Manufacturer
Cook Incorporated
Category
Medical Device — Guidewire
Hazard
  • sterility-compromise
  • packaging-breach

Distribution

Distributed nationwide across the United States.

Related recalls

Same category