—#192148

Product

PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U

FDA product code: MEA — Pump, Infusion, Pca
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K092313, K172831, K191910
Affected lot / code info: Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: B Braun Medical Inc
Address: 200 Boulder Dr, Breinigsville, Pennsylvania 18031-1532

Distribution

Distribution pattern: US Distribution to states of: MA, VT

Timeline

Recall initiated: 2022-02-07
Terminated: 2023-12-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #192148. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.