Perfusor recallZ-0819-2022 · B Braun Medical Inc · initiated Feb 7, 2022
Terminated
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
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.
FDA root cause category: Under Investigation by firm
What the company is doing
BBraun issued "URGENT MEDICAL DEVICE CORRECTION" letter on 2/7/21 to End-Users. Letter states reason for recall, health risk and action to take: 1. Review the Device Correction Notification in its entirety and ensure that all users in your organization of theabove-mentioned product, and other concerned persons are informed about this voluntary correction. 2. Identify your current inventory of the affected serial (s) within your facility, cease use and quarantine product subject to correction. Do not destroy any affected product. 3. Utilizing the attached Product Correction Acknowledgement form, record the total number of individual units. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed Product Correction Acknowledgement form to B. Braun Medical Inc. Quality Assurance department by faxing the form to (610) 849-1197 or e-mail to [email protected] within two (2) weeks of receipt, even if the total inventory in your possession is zero (0). 5. Once we have received your acknowledgement a BBMI representative will contact you to arrange for inspection and/or correction of the affected products. Should an issue occur, please report the event promptly to BBMI by contacting Medical Affairs Department at 1-800-854-6851.
Recall details
- Recall number
- Z-0819-2022
- Status
- Terminated
- Initiated by the company
- Feb 7, 2022
- Recalling firm
- B Braun Medical Inc
- Quantity
- 6 units
- Product code
- MEA
- FDA submissions
- K092313, K172831, K191910
- Distribution
- US Distribution to states of: MA, VT
Product description
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Code information (models, lots, serial numbers)
Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Perfusor® 8713030UB. Braun Medical Inc. · Pump, infusion, enteral2 recalls3 deaths76 reports
Product lines
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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