Recall Z-0951-03 ยท CPK
Respironics California Inc
ESPRIT VENTILATOR, Model V1000
| Date | Jul 1, 2003 (initiated Jun 8, 2001) |
| Status | Terminated |
| Reason | Material hardness on original design check valve may cause premature failure. |
| Root cause | Other |
| Action | Firm plans to replace all of the check valves in the field. Recall was communicated by issuance of a Field Communication 2001-25 dated 8 June 2001. |
| Quantity | 749 |
| Distribution | Throughout the US and to Vietnam,Turkey, Thailand, Spain, Singapore, Puerto Rico, Philipines, Peru, Panama, Pakistan, Mexico, Malaysia, Korea, Japan, Italy, Indonesia, Egypt, Columbia, China, Canada, Brazil, Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K981072 | ESPRIT VENTILATOR Respironics, Inc., Nov 12, 1998 |