The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1530-2024·Announced 2024-04-24

Cook Incorporated Dilators Recalled for Low Packaging Seal Strength

Cook Incorporated is recalling 5,998 dilators worldwide because packaging may not meet seal strength specifications, potentially compromising device sterility.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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 medical device recall. The packaging defect poses a risk of device contamination and loss of sterility, which could harm patients. No illnesses or injuries have been reported, and the hazard remains theoretical at this time.

Plain-English summary

Cook Incorporated is recalling 5,998 dilators (models JCD10.0-38-20, JCD20.0-38-20, JCD22.0-38-20, JCD6.0-38-15, JCD8.0-38-15, and JCD8.0-38-20) used for dilating puncture sites and catheter tracts during percutaneous placement of medical devices in vascular and non-vascular applications.

The packaging for these dilators may have low seal strength and not meet peel strength specifications. This could compromise the device sterility.

The affected dilators were distributed worldwide, including throughout the United States and to Austria, Australia, Brazil, Canada, Switzerland, Germany, Spain, United Kingdom, Hong Kong, Ireland, Israel, India, Italy, New Zealand, and Singapore. Specific lot numbers are identified in the FDA recall notice.

Healthcare facilities with these devices should verify their inventory against the affected lot numbers and contact Cook Incorporated for further instructions.

The recalled product

Product
Dilator - 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. 1) JCD10.0-38-20 2) JCD20.0-38-20 3) JCD22.0-38-20 4)…
Manufacturer
Cook Incorporated
Category
Medical Device — Vascular Accessories
Hazard
Affected units
5,998

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 (11)

  • 1)JCD10.0-38-20 (01)00827002009936(17) Lot Numbers: 15794371
  • 15794373
  • 15794374
  • 15806068
  • 15816198
  • 15816199 15816200 2) JCD20.0-38-20 (01)00827002014718(17) Lot Numbers: 15784153
  • 15784159
  • 15784160
  • 15794192
  • 15794199
  • 15797979 6) JCD8.0-38-20 (01)00827002009806(17) Lot Number:15791073

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 →

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