Z-2285-2018Class II

Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat...

Name: Z-2285-2018 Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat...
Creator: B. Braun Medical, Inc.
Published: 2018-05-09
License: https://open.fda.gov/license/

B Braun Medical Inc / initiated 2018-05-09 / Terminated / root cause: manufacturing process

FDA source

B. Braun Medical, Inc. began a recall of Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron... on 2018-05-09. FDA classified it as Class II and gives the reason as "There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter". 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-2285-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-09
Posted: 2018-06-25
Terminated: 2019-12-12
Recalling firm: B Braun Medical Inc
Product: Space Pump IV Set, 2 Caresites, ASV, 0.2 Micron Air Eliminating Filter, Product Code 363420 The Infusomat Space Pump IV Set, 2 Caresites, ASV with 0.2 Micron Air Eliminating Filter and Anti-Syphon Valve (ASV) is a latex-free product intended to be used with the Infusomat Space Pump, to deliver intravenous solutions. The 0.2 Micron filter is a clear acrylic in-line filter designed to eliminate air within the IV infusion set. While it is not listed in the labeling, it is known that the filter is used for removal of particulate matter for some medications and at risk patient populations.
Product code: FPA Set, Administration, Intravascular
Reason for recall: There is a potential for a different set to be mixed within the lot, where the incorrect set does not contain an air eliminating filter.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: B. Braun Medical Inc. sent an Urgent Voluntary Medical Device Recall Notification letter dated May 9, 2018. The letter included the following instructions for customers: 1. Review the Medical 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 and the affected product. Further use of this product should be discontinued immediately and affected product quarantined. 2. If you are a distributor, please immediately forward this recall notification to your customers. 3. Determine your current inventory of the affected lots within your facility. Do not destroy any affected product. 4. 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. 5. 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). It is important this form is returned, so BBMI can meet its United States Food and Drug Administration regulatory requirement. 6. If you have any full cases, partial cases or unused individual pieces of these affected products as identified in the " Product Removal Acknowledgement" form that was submitted to BBMI Quality Assurance Department, a BBMI 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. For further questions, please call (610) 596-0500.
Quantity in commerce: 1,872
Distribution: US Distribution to the states of : CA, IL, and TX., and Internationally to Canada.
Product codes and lots: Lot Number: 0061583973

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2285-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2285-2018	Class II	Terminated	Voluntary: Firm initiated	2018-07-04	2018-06-25

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)