FDAFDA · Food and drugs·Recall number Z-1532-2024
Dilator - Coons Taper - 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 (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20- COONS G03928 2) JCD12.0-38-20- COONS G03929 3) JCD14.0-38-20- COONS G03932 4) JCD16.0-38-20- COONS G03947 5) JCD18.0-38-20- COONS G04051 6) JCD20.0-38-20- COONS G04264 7) JCD22.0-38-20- COONS G04443 8) JCD6.0-38-20- COONS G04221 9) JCD8.0-38-20- COONS G03927
Published April 24, 2024 · Recall initiated: March 1, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Cook Incorporated
- Distributor
- Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
- Lot
- Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20- COONS (01)00827002039285(17) 15787236; 2) JCD12.0-38-20- COONS (01)00827002039292(17) 15774752, 15774753; 3) JCD14.0-38-20- COONS (01)00827002039322(17) 15797981, 15784149, 15797975 15797976, 15797982; 4) JCD16.0-38-20- COONS (01)00827002039476(17) 15794190, 15794191, 15808405; 5) JCD18.0-38-20- COONS (01)00827002040519(17) 15794189, 15797973; 6) JCD20.0-38-20- COONS (01)00827002042643(17) 15784152, 15784156, 15784158 15784164, 15794195, 15804033; 7) JCD 38-20- COONS (01)00827002044432(17) 15767086, 15784163, 15794203, 15806060; 8) JCD6.0-38-20- COONS (01)00827002042216(17) 15787237, 15787244 9) JCD8.0-38-20- COONS (01)00827002039278(17) 15797985, 15797999, 15798003
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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