Z-0810-03

Portex 1st Response Adult Manual Resuscitators Ref: 8503P

Name: Z-0810-03 Portex 1st Response Adult Manual Resuscitators Ref: 8503P
Creator: Sims Portex Inc.
Published: 2002-11-15
License: https://open.fda.gov/license/

Abbott Medical / initiated 2002-11-15 / Terminated

FDA source

Sims Portex Inc. began a recall of Portex 1st Response Adult Manual Resuscitators Ref: 8503P on 2002-11-15. The reason FDA records is "Peep valve set at the highest level and could result in patient injury". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0810-03
Status: Terminated
Initiated: 2002-11-15
Posted: 2003-05-22
Terminated: 2004-05-11
Recalling firm: Abbott Medical
Product: Portex 1st Response Adult Manual Resuscitators Ref: 8503P
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: Peep valve set at the highest level and could result in patient injury
FDA 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 in commerce: 6252 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
Product codes and lots: REF 8503P-Resuscitator 40'' tube reservoir Lot #''s 020624, 020702, 020917, 021003, 200205, 200214, 200216

Product code BTM

K014115Class II1St Response Manual Resuscitator, Model 85XxPortex, Inc. / cleared 2002-02-27

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)