The Recall Desk
HighFDA (Devices)·Z-0740-2013·Announced 2013-02-06

Cordis ExoSeal Vascular Closure Device Recalled for Sterility Assurance Failure

Cordis is recalling ExoSeal Vascular Closure Devices because the sterilization process did not meet required sterility assurance levels.

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: The recall is classified as FDA Class II. The hazard involves a failure to achieve required sterility assurance levels, which poses a risk of infection (risk-of-harm) without reported illnesses or injuries in the source text, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Cordis Corporation is recalling specific lots of the ExoSeal(TM) 6F Vascular Closure Device, including model numbers EX500, EX600, and EX700. The recall was initiated because the affected lots were sterilized using a process that did not achieve the sterility assurance level required by the standards for this class of product.

A total of 98,675 units were distributed in the United States. The distribution was nationwide, covering states including AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and Hawaii.

Healthcare providers and patients should check the lot numbers of their ExoSeal devices against the list provided in the official recall notice. If a device matches one of the affected lot numbers, it should not be used. Cordis Corporation is the recalling firm responsible for this action.

The recalled product

Product
Cordis, a Johnson and Johnson Company, ExoSeal(TM) 6F Vascular Closure Device, cat. No EX500, EX600, and EX700. Used for femoral artery puncture site closure, reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional procedures.
Manufacturer
Cordis Corporation
Category
Medical Device — Vascular Closure Device
Hazard
Affected units
98,675

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)

  • Model EX500: Lot #'s: 15410906
  • 15411659
  • 15424968
  • 15429098
  • 15429879
  • 15437509
  • 15437958
  • 15444208
  • 15449422
  • 15453540
  • 15456567
  • 15456568
  • 15462779
  • 15462780
  • 15469984
  • 15479199
  • 15481341
  • 15485491
  • 15489970
  • 15501955

Distribution

Distributed nationwide across the United States.

The notice also names 44 states specifically:

Related recalls

Same manufacturer · Cordis Corporation

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Same hazard · sterility failure

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