Cook Medical Guidewire Recall: Packaging Seal Breach May Compromise Sterility
Cook Incorporated is recalling Fixed Core Wire Guide devices due to a potential breach in the packaging seal that may compromise device sterility.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall with no reported hospitalizations or injuries. The hazard involves compromised device sterility from packaging failure, classified as a risk-of-harm product where injury has not been reported, meeting the High severity threshold.
Plain-English summary
Cook Incorporated is recalling certain Fixed Core Wire Guide (Safe-T-J Curved) devices distributed in the United States and internationally. The company identified that devices from affected lots may have a complete breach of the chevron seal on the packaging, which could compromise the sterility of the devices.
Sterile medical devices depend on their packaging integrity to prevent contamination. A breach in the packaging seal could allow microorganisms to enter, potentially affecting device safety during use in medical procedures.
The recall involves 9,903 units distributed domestically in the United States and 5,185 units distributed internationally. Affected devices are identified by specific lot numbers and UDI-DI codes listed in the FDA notice. Healthcare providers and facilities should verify whether they have received affected devices and refrain from using any devices identified as being from the recalled lots.
The recalled product
- Product
- Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412…
- Manufacturer
- Cook Incorporated
- Category
- Medical Device — Guidewire
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 24 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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