The Recall Desk
HighFDA (Devices)·Z-1532-2024·Announced 2024-04-24

Cook Coons Taper Dilators recalled due to low packaging seal strength

Cook Incorporated is recalling 4,856 Coons Taper Dilators because packaging may have low seal strength, compromising device sterility. These percutaneous dilators are used in vascular and non-vascular procedures and are distributed worldwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall for a medical device used in invasive vascular and non-vascular procedures. The hazard—packaging with low seal strength that compromises device sterility—poses a risk of infection from non-sterile devices used in percutaneous vascular access. No illnesses or injuries have been reported, placing this in the High (3) category for risk-of-harm products without reported injury.

Plain-English summary

Cook Incorporated is recalling 4,856 units of Coons Taper Dilators (Reference Part Numbers JCD10.0-38-20 through JCD22.0-38-20) due to a packaging defect. The packaging may have low seal strength and not meet peel strength specifications, which could compromise the sterility of the devices.

These dilators are used for dilating puncture sites and catheter tracts for percutaneous placement of devices in vascular and non-vascular applications, including venous, arterial, biliary, and renal systems. The recalled units have been distributed worldwide, including throughout the United States and to Austria, Australia, Brazil, Canada, Switzerland, Germany, Spain, the United Kingdom, Hong Kong, Ireland, Israel, India, Italy, New Zealand, and Singapore.

Specific lot numbers for each model are identified in the FDA recall notice. Healthcare providers and facilities with these devices in inventory should verify their lot numbers against the recall list. Devices matching the recalled lot numbers should not be used and should be removed from inventory.

No adverse events or injuries have been reported related to this recall.

The recalled product

Product
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.
Manufacturer
Cook Incorporated
Category
Medical Device — Surgical / Vascular Access Device
Hazard
Affected units
4,856

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

The notice also names 4 states specifically:

Part of a larger recall action

This product is one of 8 recalled by Cook Incorporated under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

Related recalls

Same manufacturer · Cook Incorporated

See all →

Same hazard · sterility compromise

See all →