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Terminated

Portex 1st Response Adult Manual Resuscitators Ref: 8500P

FDA Recall Z-0809-03 · Posted 2003-05-22

Recalling FirmSims Portex Inc.
Recall StatusTerminated
Product CodeBTM
Date Initiated2002-11-15
Date Terminated2004-05-11
Product Quantity2976

Reason for Recall

Peep valve set at the highest level and could result in patient injury

Firm 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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXPortex, Inc. · 2002-02-27

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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