Z-0819-2022Class II

Perfusor Space - US Version

Name: Z-0819-2022 Perfusor Space - US Version
Creator: B Braun Medical Inc
Published: 2022-02-07
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2022-02-07 / Terminated / root cause: labeling and UDI

FDA source

B Braun Medical Inc began a recall of PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U on 2022-02-07. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0819-2022
Classification: Class II
Status: Terminated
Initiated: 2022-02-07
Posted: 2022-03-22
Terminated: 2023-12-28
Recalling firm: B Braun Medical Inc
Product: PERFUSOR SPACE - US VERSION. Intended Use: syringe infusion pump that can be used to configure customized, tailor-made solutions Catalog Number: 8713030U
Product code: MEA Pump, Infusion, Pca
Reason for recall: 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 tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 6 units
Distribution: US Distribution to states of: MA, VT
Product codes and lots: Serial Numbers: 633299, 633307, 633310, 633313, 633315, 633318 GUIDID: 04046963716745

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0819-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0819-2022	Class II	Terminated	Voluntary: Firm initiated	2022-03-30	2022-03-22

Product code MEA

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)