Recall Z-0819-2022— B Braun Medical Inc
Class II · Terminated
Class II FDA medical device recall by B Braun Medical Inc, initiated 2022-02-07, terminated 2023-12-28. It names 3 FDA 510(k) clearances: K191910, K172831, K092313. 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..
- Recalling firm
- B Braun Medical Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2022-02-07
- Terminated
- 2023-12-28
- Firm location
- Breinigsville, PA, United States
510(k) clearances named in this recall
3 on FDA's record- K191910 — SpaceStation MRI
- K172831 — Perfusor® Space Syringe Infusion Pump System
- K092313 — PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.