B Braun Medical Inc PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Brand
B Braun Medical Inc
Lot Codes / Batch Numbers
Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745
Products Sold
Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745
B Braun Medical Inc is recalling PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure custo due to Units not properly inspected prior to release to the market, may not function as indicated in the product labeling, resulting in syringe detection and. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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 PA_QualityAssurance.BBMUS_Service@bbraunusa.com 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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
MA, VT
Page updated: Jan 10, 2026