Portex 1st Response Adult Manual Resuscitators recallZ-0808-03 · Sims Portex Inc. · initiated Nov 15, 2002
Terminated All recalls posted in May 2003
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Sims Portex Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Peep valve set at the highest level and could result in patient injury
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0808-03
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 15, 2002
- Posted by the FDA
- May 22, 2003
- Recalling firm
- Sims Portex Inc.
- Quantity
- 1188 units
- Product code
- BTM
- FDA submissions
- K014115
- 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
Product description
Portex 1st Response Adult Manual Resuscitators Ref: 8506P
Code information (models, lots, serial numbers)
REF 8506P-Resuscitator, expandable tube reservoir, peep valve Lot #''s 020624, 020705, 021003, 200205, 200214, 200216
Other devices under the same FDA submission
5 devices cleared under K014115 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Portex 8506PIcu Medical, Inc. · Ventilator, emergency, manual (resuscitator)2 reports
- Portex 8500Icu Medical, Inc. · Ventilator, emergency, manual (resuscitator)1 report
- Portex 8503Icu Medical, Inc. · Ventilator, emergency, manual (resuscitator)1 report
- Portex 8501Icu Medical, Inc. · Ventilator, emergency, manual (resuscitator)1 report
- Portex 8503FIcu Medical, Inc. · Ventilator, emergency, manual (resuscitator)1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 25083).
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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