Class 2 Device Recall Bemis

• Date Initiated by Firm: February 25, 2004
• Date Posted: July 20, 2004
• Recall Status: Terminated on June 24, 2004
• Recall Number: Z-0789-04
• Recall Event ID: 28497
• 510(K)Number: K965248
• Product Classification: Container, Sharps - Product Code MMK
• Product: Bemis Two-Gallon Sharps Container, Models #102 020, #102 030, and #102 040. (The only difference between the models is in color. Model 102 040 is yellow, Model 102 020 is beige and Model 102 030 is red. )
• Code Information: Lot #20040001 and Lot #20040004
• Recalling Firm/ Manufacturer: Bemis Manufacturing Co.; Highway Pp West; Sheboygan Falls WI 53085
• For Additional Information Contact: John B. Howell; 920-467-5206
• Manufacturer Reason for Recall: The closure flap of the recalled sharps containers have two tabs that fit into slots on the cover for final closure and locking but some of the covers have one of the tabs that will not fit into the designated slot because the slot is occluded with plastic.
• FDA Determined Cause: Other
• Action: Recall letters dated 2/25/04 requested the return of the product and providing for notification of the subaccounts that may have received the product.
• Quantity in Commerce: 1920 containers
• Distribution: The recalled containers were shipped to consignees in Connecticut, Florida, Georgia, Pennsylvania and Tennessee in the United States, and to a consignee in Canada.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MMK