Recall Z-0808-03 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Sims Portex Inc.
Portex 1st Response Adult Manual Resuscitators Ref: 8506P
| Date | May 22, 2003 (initiated Nov 15, 2002) |
| Status | Terminated |
| Reason | Peep valve set at the highest level and could result in patient injury |
| Root 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 | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014115 | 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX Portex, Inc., Feb 27, 2002 |