Recalls / —

—#188070

Product

Infusomat Space Volumetric Pump Administration Set, Product Code 490100

FDA product code

FPA — Set, Administration, Intravascular

Device class

Class 2

Medical specialty

General Hospital

510(k) numbers

K142036

Affected lot / code info

Lot Number: 0061761278

Why it was recalled

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 (FDA determination)

Process control

Action the firm took

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 PA_QualityAssurance.BBMUS_Service@bbraunusa.com 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.

Recalling firm

Firm

B. Braun Medical, Inc.

Address

901 Marcon Blvd, Allentown, Pennsylvania 18109-9512

Distribution

Distribution pattern

Affected products were distributed to the following US states: CA, MI, OR, and UT.

Timeline

Recall initiated

2021-06-25

Terminated

2023-10-16

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #188070. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.