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U.S. Department of Health and Human Services

Class 2 Device Recall Perfusor Space

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 Class 2 Device Recall Perfusor Spacesee related information
Date Initiated by FirmJune 14, 2024
Date PostedJuly 25, 2024
Recall Status1 Open3, Classified
Recall NumberZ-2435-2024
Recall Event ID 94890
510(K)NumberK092313 K191910 
Product Classification Pump, infusion - Product Code FRN
ProductBrand 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 Lot Code: Model No 8713080U; UDI-DI 4046963915308; All Serial Numbers
Recalling Firm/
Manufacturer		 B Braun Medical Inc
200 Boulder Dr
Breinigsville PA 18031-1532
For Additional Information ContactAllison Longenhagen
001-484-2408373
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionOn 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.
Quantity in Commerce1663
DistributionDomestic distribution nationwide. International distribution to Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = FRN
510(K)s with Product Code = FRN
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