Reported Apr 24, 2024 · Ongoing
Dilator - Coons Taper - Used for dilating puncture sites or catheter tracts for percutaneous placement of devices for…
Cook Incorporated
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Cook Incorporated · 750 N Daniels Way · Bloomington, IN · 47404-9120
Is this the product you have?
9 of 9 products
| Model / number | Product as published |
|---|---|
G03928 | 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 |
G03929 | 2) JCD12.0-38-20- COONS |
G03932 | 3) JCD14.0-38-20- COONS |
G03947 | 4) JCD16.0-38-20- COONS |
G04051 | 5) JCD18.0-38-20- COONS |
G04264 | 6) JCD20.0-38-20- COONS |
G04443 | 7) JCD22.0-38-20- COONS |
G04221 | 8) JCD6.0-38-20- COONS |
G03927 | 9) JCD8.0-38-20- COONS |
- Lot codes and dates
9 of 9 products
Products covered by this recall # Barcodes Product as published 1 00827002039285JCD10.0-38-20- COONS (01)00827002039285(17) 15787236 2 00827002039292JCD12.0-38-20- COONS (01)00827002039292(17) 15774752, 15774753 3 00827002039322JCD14.0-38-20- COONS (01)00827002039322(17) 15797981, 15784149, 15797975 15797976, 15797982 4 00827002039476JCD16.0-38-20- COONS (01)00827002039476(17) 15794190, 15794191, 15808405 5 00827002040519JCD18.0-38-20- COONS (01)00827002040519(17) 15794189, 15797973 6 00827002042643JCD20.0-38-20- COONS (01)00827002042643(17) 15784152, 15784156, 15784158 15784164, 15794195, 15804033 7 00827002044432JCD 38-20- COONS (01)00827002044432(17) 15767086, 15784163, 15794203, 15806060 8 00827002042216JCD6.0-38-20- COONS (01)00827002042216(17) 15787237, 15787244 9 00827002039278JCD8.0-38-20- COONS (01)00827002039278(17) 15797985, 15797999, 15798003 - Amount recalled
- 4,856 units
This recall covers 8 products
The agency filed one notice per product. You are reading one of them; the other 7 are below.
Where it was sold
Why it was recalled
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Cook Incorporated recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.