Perfusor recallZ-2435-2024 · B Braun Medical Inc · initiated Jun 14, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from B Braun Medical Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Device Design
What the company is doing
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.
Recall details
- Recall number
- Z-2435-2024
- Status
- Open, Classified
- Initiated by the company
- Jun 14, 2024
- Posted by the FDA
- Jul 25, 2024
- Recalling firm
- B Braun Medical Inc
- Quantity
- 1663
- Product code
- FRN
- FDA submissions
- K191910, K092313
- Distribution
- Domestic distribution nationwide. International distribution to Canada.
Product description
Brand Name: Perfusor Space Product Name: Perfusor PCA Syringe Pump Model/Catalog Number: 8713080U Product Description: Perfusor Space Syringe Pump, Infusion Pump, 1 each Component: N/A
Code information (models, lots, serial numbers)
Lot Code: Model No 8713080U; UDI-DI 4046963915308; All Serial Numbers
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Perfusor® 8713080UB. Braun Medical Inc. · Pump, infusion1 recall12 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 94890).
- Z-2433-2024 · Open, ClassifiedBrand Name: Perfusor Space Product Name: Perfusor Space Infusion Pump System Model/Catalog Number: 8713030U Product Description: Perfusor Space Infusion Pump System, Infusion Pump,…
- Z-2434-2024 · Open, ClassifiedBrand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Wireless Model/Catalog Number: 8713031U Software Version: 8713031U Product Description: Perfusor Space Syringe…
- Z-2436-2024 · Open, ClassifiedBrand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each Component: N/A
- Z-2437-2024 · Open, ClassifiedBrand Name: Perfusor Space Product Name: Perfusor Space Syringe Pump, Non-Wireless Model/Catalog Number: 8713032U Product Description: Perfusor Space Syringe Pump, Non-Wireless, In…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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