Recall Z-1526-2024— Cook Incorporated
Class II · Ongoing
Class II FDA medical device recall by Cook Incorporated, initiated 2024-03-01. FDA's recall record names no specific 510(k) clearance for this event. 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): G01377. Reason: Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility.
- Recalling firm
- Cook Incorporated
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-03-01
- Firm location
- Bloomington, IN, United States
Product description
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): G01377
Reason for recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Data sourced from openFDA. This site is unofficial and independent of the FDA.