Medline ACME Monaco Guidewire Recall for Defective Coating

February 25, 2014 — Medline Industries has recalled the ACME Monaco Guidewire because the coating can flake off the wire, which may result in serious adverse health consequences.

The U.S. Food and Drug Administration (FDA) has designated the action a Class 1 recall because there is a reasonable probability that the defect could cause severe injuries or death.

Medline initiated the recall on August 14, 2013 with a Recall Notification to inform customers of the problem. The affected products were distributed from March 2013 through August 2013.

The guidewire is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel. It is used in various surgical convenience kits manufactured by Medline Industries.

Product:

  • ACME Monaco Guidewire .035×150 3MMJ TCFC item 88241

Product codes and lot numbers:

  • 054372-1-1A
  • 054372-1-1B
  • 054372-1-2A

Recommendation:

“The affected guidewires should be removed from the kit and returned to Medline. The rest of the kit may be used and the affected guidewire may be replaced with a sterile product from supply. If additional stickers are needed, please call 1-866-359-1704.”

Medtronic Guidewire Recall

The Medline recall is very similar to another Class 1 recall issued by Medtronic in November 2013, in which cardiac device guidewires were recalled because the coating on their surface could delaminate and detach. Guidewires in the following product lines were affected:

  • Cougar nitinol workhorse guidewire
  • Cougar steerable guidewire
  • Zinger stainless steel workhorse guidewire
  • Zinger steerable guidewire
  • Thunder extra-support guidewire
  • Thunder steerable guidewire
  • ProVia crossing guidewire
  • Attain Hybrid guidewire

Need a Texas ACME Monaco Guidewire Lawyer?

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $260 million in verdicts and/or settlements. Please use the form below to contact our Texas ACME Monaco Guidewire lawyers for a free lawsuit review.

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Collen A. Clark

Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.

“Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”

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