Cadd Medication Cassette Reservoir

• 9 recalls, same reason

  • Ongoing Z-0016-2025 FDA Class II ·initiated 26 Jun 2024
  • Ongoing Z-0018-2025 FDA Class II ·initiated 26 Jun 2024
  • Ongoing Z-0014-2025 FDA Class II ·initiated 26 Jun 2024
  • Ongoing Z-0012-2025 FDA Class II ·initiated 26 Jun 2024
  • Ongoing Z-0011-2025 FDA Class II ·initiated 26 Jun 2024
  • Ongoing Z-0015-2025 FDA Class II ·initiated 26 Jun 2024
  • Ongoing Z-0010-2025 FDA Class II ·initiated 26 Jun 2024
  • Ongoing Z-0017-2025 FDA Class II ·initiated 26 Jun 2024
  • Ongoing Z-0013-2025 FDA Class II ·initiated 26 Jun 2024

  Certain CADD Medication Cassette Reservoirs may exhibit a weakened weld joint between the medication bag and tubing due to a production equipment malfunction. This could result in a medication leakage.

• • Ongoing Z-0964-2023 FDA Class I ·initiated 9 Dec 2022

  There are two potential issues with CADD Infusion System Infusion Sets: (1) Lack of Delivery or Underdelivery related to Tubing Occlusion and (2) False "No Disposable Attached (NDA)" Alarms

510(k) Number

K081156 ↗

FDA Product Code

FPA

Device Class

Class II

Regulation

21 CFR Part 880.5440

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• Port-A-Cath, Port-a-Cath II, Proport and P.A.S. Port Implantable Venous Access Systems with Dual Layer Catheter

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  FDA 510(k) K060036 Active Cleared 17 May 2006

• Cadd Administration Set with Flow Stop, Medication Cassette Reservoir with Flow Stop and Extension Set Open recall

  Class II

  FDA 510(k) K040636 Active Cleared 19 May 2004

• Gripper Micro Needle

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