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.
- ACME Monaco Guidewire .035×150 3MMJ TCFC item 88241
Product codes and lot numbers:
“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
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