Recall archive / FDA device enforcement
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-mad... — FDA record Z-0819-2022
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 7, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
- Reason
- Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and infusion accuracy that can result in delays in therapy, overinfusion, or underinfusion.
- Classification
- Class II
- Recalling firm
- B Braun Medical Inc
- Quantity
- 6 units
- Agency-reported status
- Terminated
- Source record identifier
- Z-0819-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
US Distribution to states of: MA, VT
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Mar 30, 2022
- Recall initiation date
- Feb 7, 2022
- Center classification date
- Mar 22, 2022
- Termination date
- Dec 28, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.