CLASS II ONGOING Device recall · Reported 24 Apr 2024 · FDA Enforcement Report
Dilator With AQ Hydrophilic Coating recalled by Cook Incorporated
Cook Incorporated is recalling Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or, distributed nationwide in the US. The recall was initiated on 1 Mar 2024 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1531-2024
- FDA event ID
- 94196
- Recalling firm
- Cook Incorporated, Bloomington, IN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Mar 2024
- FDA classified
- 12 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Heart & Vascular Devices
Timeline
| 1 Mar 2024 | Recall initiated by company | |
| 12 Apr 2024 | Classified by FDA | +42 days |
| 24 Apr 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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 G10207 2) JCD14.0-38-20-HC G10293 3) JCD16.0-38-20-HC G10206 4) JCD6.0-38-20-HC G10285 5) JCD8.0-38-20-HC G10289
Where it was distributed
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
Questions about this recall
Is Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or recalled?
Yes. Cook Incorporated recalled Dilator With AQ Hydrophilic Coating - Intended to be used for dilating puncture sites or on 1 Mar 2024. The recall is Class II and its status is Ongoing. Recall number Z-1531-2024.
Why was it recalled?
Packaging may have low seal strength and not meet peel strength specifications, compromising device sterility
Which lots are affected?
Ref. Number/UDI-DI/Lot Numbers: 1) JCD10.0-38-20-HC (01)00827002102071(17) 15794369 2) JCD14.0-38-20-HC (01)00827002102934(17) 15778297, 15787264 3) JCD16.0-38-20-HC (01)00827002102064(17) 15794375 4)JCD6.0-38-20-HC (01)00827002102859(17) NS15808469 5) JCD8.0-38-20-HC (01)00827002102897(17) 15761259
Where was it sold?
Worldwide distribution - US Nationwide and the countries of AT, AU, BR, CA, CH, DE, ES, GB, HK, IE, IL, IN, IT, NZ, SG.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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