Class 2 Device Recall Portex

• Date Initiated by Firm: February 21, 2005
• Date Posted: April 27, 2005
• Recall Status: Terminated on December 20, 2006
• Recall Number: Z-0764-05
• Recall Event ID: 31451
• Product Classification: Circuit, Breathing (W Connector, Adaptor, Y Piece) - Product Code CAI
• Product: Portex Adult Single Limb Anesthesia Breathing Circuit, single use, Part Numbers: 386000 and 384001. Manufactured for Sims Portex, Inc., Fort Meyers, FL, Made in Mexico.
• Code Information: Part Number 384001, 20 per case, Lot numbers: 551880804, 581451104, 581461104; Part Number 386000, 15 per case, Lot numbers: 551890804, 600080205, 5518908004
• Recalling Firm/ Manufacturer: MMS Sales Corp; 218 Highline Rd; Pharr TX 78577-9726
• Manufacturer Reason for Recall: Partial occlusion in the T-piece resulting in airway obstruction.
• FDA Determined Cause: Other
• Action: The firm initiated the recall on February 21, 2004 by letter to all consignees.
• Quantity in Commerce: Total for all products: 7455 cases (161,273 units)
• Distribution: Product was distributed domestically to customers in CA, AZ, IL, CO, OR, FL, VA, OH, MI, and UT. Product was also distributed to the following foreign countries: Malaysia, Mexico, and New Zealand
• 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.