Z-2436-2024Class II

Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product...

Name: Z-2436-2024 Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product...
Creator: B Braun Medical Inc
Published: 2024-06-14
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2024-06-14 / Open, Classified / root cause: design

FDA source

B Braun Medical Inc began a recall of Brand Name: Perfusor Space Product Name: PERFUSOR SPACE ACM-KIT Model/Catalog Number: 8713040U Product Description: Perfusor Space, Infusion Pump Kit, 1 each... on 2024-06-14. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as design.

Recall record

Recall number: Z-2436-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-06-14
Posted: 2024-07-25
Recalling firm: B Braun Medical Inc
Product: Brand 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
Product code: FRN Pump, Infusion
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.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 930
Distribution: Domestic distribution nationwide. International distribution to Canada.
Product codes and lots: Lot Code: Model No 8713040U; UDI-DI 4046963687182; All Serial Numbers

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2436-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2433-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2434-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2435-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2436-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25
Z-2437-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-07-31	2024-07-25

Product code FRN

K092313Class IIPerfusor Space Infusion Syringe Pump SystemB.Braun Medical, Inc. / cleared 2009-11-04

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)