Home / Recalls / CAREFUSION / Z-1995-2021

Z-1995-2021 Class II Terminated

Recalled by CAREFUSION — San Diego, CA

FDA device recall Z-1995-2021 was initiated by CAREFUSION on June 9, 2021 and is designated Class II. Reason for recall: A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage. The recall status is terminated (terminated July 8, 2024). Affected quantity: 100 units.

Recall Details

Product Type
Devices
Report Date
July 7, 2021
Initiation Date
June 9, 2021
Termination Date
July 8, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
100 units

Product Description

MaxPlusTM bi fuse extension set with 2 clear needleless connectors - Product Usage: The needleless connector can be used for direct injection, intermittent infusion, continuous infusion, or aspiration.

Reason for Recall

A portion of a validation lot was inadvertently released to the US Market. The product did not meet the validation testing criteria regarding leakage.

Distribution Pattern

U.S.: TN O.U.S.: None

Code Information

Catalog Number:MP9246-C GTIN: 10885403237157 Lot Number: 20087194

Other recalls by CAREFUSION

  • Z-1755-2022 Class II — BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 (August 1, 2022)
  • Z-1753-2022 Class II — BD MaxGuard Extension Set, REF: ME1069 (August 1, 2022)
  • Z-1759-2022 Class II — BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9 (August 1, 2022)
  • Z-1760-2022 Class II — BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 (August 1, 2022)
  • Z-1752-2022 Class II — BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 (August 1, 2022)
  • Z-1756-2022 Class II — BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port M (August 1, 2022)
  • Z-1758-2022 Class II — BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9 (August 1, 2022)
  • Z-1754-2022 Class II — BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 (August 1, 2022)
  • Z-1757-2022 Class II — BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 (August 1, 2022)
  • Z-2460-2021 Class II — BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite (August 2, 2021)

FDA data resources