B BRAUN MEDICAL INC: Device Recall

Recall Details

Recall Number

Z-2176-2025

Classification

Class I

Product Type

Device

Recalling Firm

B BRAUN MEDICAL INC

Status

Ongoing

Date Initiated

07/09/2025

Location

Allentown, PA, United States

Voluntary/Mandated

Voluntary: Firm initiated

Product Quantity

34,825 units US

Reason for Recall

Label is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension set is not indicated for removal of air and does not feature an air vent, which is common to air eliminating filters.

Product Description

Microbore Extension Set with 0.2 Micron Filter. Catalog Number: V6215. for use with IV tubing.

Distribution Pattern

US distribution to AZ, CA, CO, CT, FL, GA, HI, IL, IN, KS, MA, MD, ME, MI, MN, MO, MS, NC, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WY. International distribution to Canada.

Other Recalls by B BRAUN MEDICAL INC

• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).
• Class II: Risk 10/29/2025
  Potential for backflow of medication from secondary (piggyback) IV containers into primary IV containers and the inability to prime (occlusion).

View all recalls by B BRAUN MEDICAL INC →