Class 1 Device Recall Portex 1st Response Adult Manual Resuscitators

• Date Initiated by Firm: November 15, 2002
• Date Posted: May 22, 2003
• Recall Status: Terminated on May 11, 2004
• Recall Number: Z-0808-03
• Recall Event ID: 25083
• 510(K)Number: K014115
• Product Classification: Ventilator, Emergency, Manual (Resuscitator) - Product Code BTM
• Product: Portex 1st Response Adult Manual Resuscitators Ref: 8506P
• Code Information: REF 8506P-Resuscitator, expandable tube reservoir, peep valve Lot #''s 020624, 020705, 021003, 200205, 200214, 200216
• Recalling Firm/ Manufacturer: Sims Portex Inc.; 10 Bowman Drive; Keene NH 03431
• For Additional Information Contact: Timothy J. Talcott; 2457-603-352 Ext. 3812
• Manufacturer Reason for Recall: Peep valve set at the highest level and could result in patient injury
• FDA Determined Cause: Other
• Action: Portex notiifed direct customers by telephone (medical facilities and distributors) on 11/15/2002 and 11/18/2002 inforrming them to isolate and hold inventory. A letter dated 11/19/02 issued by Fed''X to return product or remove/discard PEEP valve from unit and complete the response form.
• Quantity in Commerce: 1188 units
• Distribution: Nationwide. AL, CA, CO, IA, IL, FL, GA, LA, KS, KY, MA, ME, MN, MO, MS, NC,NM, NY, OK, SC, TN, TX, WA WY, UT, VA
• 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 = BTM