Smiths Pneupac babyPAC portable ventilator, model 100. Designed for use by qualified medical caregivers, paramedics and
FDA device recall Z-0436-06 · posted 2006-01-24 · Terminated
Recall details
- Recalling firm
- Smiths Medical PM, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- BTL
- Quantity affected
- 44
- Distribution
- CA, CO, IN,MN, NY, PA, TN, TX
- Date initiated
- 2005-12-05
- Date posted
- 2006-01-24
- Date terminated
- 2006-12-26
- Location
- Waukesha, WI
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