Dilators With AQ Hydrophilic Coating recalled due to packaging seal defects
Cook Incorporated is recalling 1,493 Dilators With AQ Hydrophilic Coating due to packaging that may not maintain proper seal strength, potentially compromising 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 involving potential sterility compromise on an invasive medical device with no reported illnesses or injuries, meeting the rubric criterion for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cook Incorporated is recalling 1,493 units of Dilator With AQ Hydrophilic Coating worldwide. These medical devices are used for dilating puncture sites and catheter tracts during percutaneous placement of medical devices in vascular and non-vascular applications, including the venous, arterial, biliary, and renal systems.
The recall was initiated because the device packaging may have low seal strength and not meet peel strength specifications. This defect could compromise the sterility of the device, increasing the risk of contamination.
The affected devices have been distributed to the United States and 14 other countries. Healthcare facilities and providers who have received these devices should contact Cook Incorporated to determine if they have affected units and to obtain replacement devices.
The recalled product
- Product
- Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems. REFERENCE PART NUMBER…
- Manufacturer
- Cook Incorporated
- Affected units
- 1,493
Distribution
Part of a larger recall action
This product is one of 8 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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