Reported Apr 24, 2024 · Ongoing
Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or catheter tracts 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?
5 of 5 products
| Model / number | Product as published |
|---|---|
G10207 | 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 (RPN)/ORDER NUMBER (GPN): 1) JCD10.0-38-20-HC |
G10293 | 2) JCD14.0-38-20-HC |
G10206 | 3) JCD16.0-38-20-HC |
G10285 | 4) JCD6.0-38-20-HC |
G10289 | 5) JCD8.0-38-20-HC |
- Lot codes and dates
4 of 4 products
Products covered by this recall # Barcodes Product as published 1 00827002102071JCD10.0-38-20-HC (01)00827002102071(17) 15794369 2 00827002102934JCD14.0-38-20-HC (01)00827002102934(17) 15778297, 15787264 3 0082700210206400827002102859JCD16.0-38-20-HC (01)00827002102064(17) 15794375 4)JCD6.0-38-20-HC (01)00827002102859(17) NS15808469 4 00827002102897JCD8.0-38-20-HC (01)00827002102897(17) 15761259 - Amount recalled
- 1,493 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.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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