Z-2137-2021Class II

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

Name: Z-2137-2021 Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Creator: B. Braun Medical, Inc.
Published: 2021-06-25
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2021-06-25 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Infusomat Space Volumetric Pump Administration Set, Product Code 490100 on 2021-06-25. FDA classified it as Class II and gives the reason as "There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2137-2021
Classification: Class II
Status: Terminated
Initiated: 2021-06-25
Posted: 2021-07-23
Terminated: 2023-10-16
Recalling firm: B Braun Medical Inc
Product: Infusomat Space Volumetric Pump Administration Set, Product Code 490100
Product code: FPA Set, Administration, Intravascular
Reason for recall: There is a potential for the Anti-free flow clip of the administration set to be inverted which may cause unintended free flow if the user fails to follow on screen prompt to close the roller clamp prior to set removal from the pump.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Urgent Medical Device Recall Notification letters dated 6/25/21 were sent to customers. Actions Required By BBMI Customer/User: 1. Review the Device Recall Notification in its entirety and ensure that all users in your organization of the above-mentioned product, and other concerned persons, are informed about this voluntary product recall. If you are a distributor, please forward this recall notification to your customers. The recall is to be extended to the customer level. 2. Determine your current inventory of the affected lot within your facility, cease use and quarantine product subject to recall. Do not destroy any affected product. 3. Utilizing the attached "Product Removal Acknowledgement," form, record the total number of individual units (within partial cases) and the number of full-unopened cases. If you have no inventory remaining, please enter zero (0) on the form. 4. Return the completed "Product Removal 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. If you have any full cases, partial cases or unused individual pieces of this affected product as identified in the "Product Removal Acknowledgement" form that was submitted to BBMI Quality Assurance Department, a BBMl Customer Support Representative will contact you to provide instructions for handling the affected product and arrange for return to BBMI. This may include credit or replacement product. Should you identify product where this issue has occurred, please report the event promptly to BBMI by contacting our Medical Affairs Department at 1-800-854-6851.
Quantity in commerce: 36,144 units
Distribution: Affected products were distributed to the following US states: CA, MI, OR, and UT.
Product codes and lots: Lot Number: 0061761278

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2137-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2137-2021	Class II	Terminated	Voluntary: Firm initiated	2021-08-04	2021-07-23

Product code FPA

K142036Class IIInfusomat Space Volumetric Infusion Pump Administration SetsB.Braun Medical, Inc. / cleared 2014-08-25

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)