Z-0436-06

Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers...

Name: Z-0436-06 Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers...
Creator: Smiths Medical PM, Inc.
Published: 2005-12-05
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-12-05 / Terminated

FDA source

Smiths Medical PM, Inc. began a recall of Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital... on 2005-12-05. The reason FDA records is "A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0436-06
Status: Terminated
Initiated: 2005-12-05
Posted: 2006-01-24
Terminated: 2006-12-26
Recalling firm: Abbott Medical
Product: Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and other trained personnel, for hospital, emergency and transport ventilation of patients during respiratory distress or insufficiency.
Product code: BTL Ventilator, Emergency, Powered (Resuscitator)
Reason for recall: A potential safety related problem associated with the Pnuepac babyPac Ventilator model 100 has been discovered in that the interface between the air input hose and the air input fitting may leak, and if tightened too much, the air input fitting may loosen when trying to remove the air hose.
FDA root cause: Other
Action: Consignees were provided a Safety Action Bulletin, number 05-SAB05, dated 12/05/05. This requests that affected devices be quarantined, Smiths Medical be contacted and devices ultimately be returned to Smiths Medical Pm, Inc. Service Departmentfor repair.
Quantity in commerce: 44
Distribution: CA, CO, IN,MN, NY, PA, TN, TX
Product codes and lots: 0504244, 0505158, 0506211, 0506218, 0506242, 0506248, 0506254, 0506265, 0506283, 0506289, 0506321, 0506346, 0506358, 0507127, 0507139, 0507234, 0507235, 0507236, 0507248, 0507249, 0507265, 0508173, 0508174, 0508195, 0508196, 0508197, 504227, 504254, 505139, 505142, 505145, 505257, 505271, 505276, 505286, 506155, 506158, 506169, 506171, 506194, 506233, 506241, 506343, 507317

Product code BTL

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)