Portex 1st Response Adult Manual Resuscitators Ref: 8500P
FDA device recall Z-0809-03 · posted 2003-05-22 · Terminated
Recall details
- Recalling firm
- Sims Portex Inc.
- Reason for recall
- Peep valve set at the highest level and could result in patient injury
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTM
- Quantity affected
- 2976
- 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
- Date initiated
- 2002-11-15
- Date posted
- 2003-05-22
- Date terminated
- 2004-05-11
- Location
- Keene, NH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 1ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XX (K014115) | Portex, Inc. | 2002-02-27 |