Trocar Needle Recall Due to Packaging Seal Strength Defect
Cook Incorporated recalled 55 Trocar Needles (Lot 15786588) due to packaging that may not meet peel strength specifications, potentially compromising device sterility. Units were distributed nationwide 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: This is an FDA Class II medical device recall for a sterility-compromise risk. Although no injuries or illnesses have been reported, the potential for contamination of a sterile surgical device presents a risk-of-harm scenario justifying a High severity rating.
Plain-English summary
Cook Incorporated has recalled Trocar Needles (Reference Part Number DTN-18-20.0, Order Number G01377) due to a packaging defect. The packaging may have low seal strength and not meet peel strength specifications, which could compromise the device's sterility.
Trocar Needles are used for dilating puncture sites and catheter tracts for percutaneous placement of devices in vascular and non-vascular applications, including venous, arterial, biliary, and renal systems. The recall affects 55 units with Lot Number 15786588.
The affected devices were distributed worldwide, including throughout the United States and in Austria, Australia, Brazil, Canada, Switzerland, Germany, Spain, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, New Zealand, and Singapore. No illnesses or injuries have been reported in association with this defect.
Healthcare facilities and users who have received these devices should contact Cook Incorporated for instructions on return or replacement.
The recalled product
- Product
- Trocar Needle - 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 system REFERENCE PART NUMBER (RPN): DTN-18-20.0 ORDER NUMBER (GPN): G013
- Manufacturer
- Cook Incorporated
- Hazard
- sterility-compromise
- packaging-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI: (01)00827002013773(17) Lot Number: 15786588
Distribution
Distributed nationwide across the United States.
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