FDA Medical Device Recalls (openFDA)
Sims Portex Inc.: Portex 1st Response Adult Manual Resuscitators Ref: 8506P
- Recall number
- Z-0808-03
- Recalling firm
- Sims Portex Inc.
- Product
- Portex 1st Response Adult Manual Resuscitators Ref: 8506P
- Status
- Terminated
- Initiated
- 2002-11-15
- Posted
- 2003-05-22
- Terminated
- 2004-05-11
- 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
- Lot, serial or model codes
- REF 8506P-Resuscitator, expandable tube reservoir, peep valve Lot #''s 020624, 020705, 021003, 200205, 200214, 200216
- 510(k) numbers
- ["K014115"]
- PMA numbers
- not on file
- Product code
- BTM
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28