ClearanceBrief
Recall Z-1949-2021 ยท LRO General Surgery Tray

Medical Action Industries, Inc. 306

Medical Action INDUSTRIES INC., Minor Procedure Tray, REF 61214

DateMay 11, 2021
StatusTerminated
ReasonThere is a potential for flaking metal and/or brown spots on the hemostats sold as individual units or packaged in the kits
Root causeProcess control
ActionMedical Action Industries, Inc. initiated the recall by email on 05/11/2021 Distributors were instructed to notify their customers. The firm is requesting those in possession of the recalled articles discard them.
Quantity31 cases of 20 units
DistributionUS Nationwide distribution in the states of OH, CO, CA, IL, FL, VA, TX, MN, GA, WA, MA, MD, NY, LA, AZ, OR.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.