MedStream MS994

• Ongoing Z-3158-2026 FDA Class II ·initiated 12 May 2026

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid path, which if seen by a healthcare provider may lead to replacement of product before use, which could result in a delay in therapy.

• Ongoing Z-3160-2026 FDA Class II ·initiated 12 May 2026

Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration and particulate matter in the fluid path has not been ruled out.

2 recalls, same reason

• Ongoing Z-1565-2021 FDA Class II ·initiated 16 Mar 2021
• Ongoing Z-1566-2021 FDA Class II ·initiated 16 Mar 2021

Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position.

• Ongoing Z-0701-2021 FDA Class II ·initiated 31 Aug 2020

Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to patient blood, or fluid path air-in-line.

2 recalls, same reason

• Terminated Z-1092-2019 FDA Class I ·initiated 21 Feb 2019
• Terminated Z-1093-2019 FDA Class I ·initiated 21 Feb 2019

There is a potential for certain lots of ChemoLock and ChemoClave Vial Spikes to have plastic burr particulate originating from the protective cap used in the assembly of the device.