Brand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software V
FDA device recall Z-2434-2024 · posted 2024-07-25 · Open, Classified
Recall details
- Recalling firm
- B Braun Medical Inc
- Reason for recall
- Perfusor Space Syringe Pump's instructions for use previously identified Monoject syringes as an option for use. However, changes to manufacturing to Cardinal Health Monoject syringes may result in issues with recognition, compatibility, and pump performance, such as overdose, underdose, delay in therapy, delay in occlusion alarms, and delay in feeding. Cardinal Health Monoject syringes are not compatible with the indicated pumps.
- Action taken
- On June 14, 2024, the firm notified customers via URGENT MEDICAL DEVICE FIELD CORRECTION NOTIFICATION letters. Customers were advised to not use the recalled syringes in Perfusor Space Syringe Pumps. All users should be informed of the correction. Customers were provided with an attachment to post in care areas as a reminder to not use the recalled syringes with the specified pumps.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- FRN
- Quantity affected
- 9943
- Distribution
- Domestic distribution nationwide. International distribution to Canada.
- Date initiated
- 2024-06-14
- Date posted
- 2024-07-25
- Location
- Breinigsville, PA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SpaceStation MRI (K191910) | B. Braun Melsugen AG | 2020-03-12 |
| Perfusor® Space Syringe Infusion Pump System (K172831) | B.Braun Medical, Inc. | 2018-06-12 |