ROi CPS LLC: Medical Device Recall in 2020 - (Recall #: Z-2465-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2020.

Data Source: FDA.

Product Description:

Isolation Droplet Bundle Kit

Product Classification:

Class II

Date Initiated: May 19, 2020

Date Posted: July 8, 2020

Recall Number: Z-2465-2020

Event ID: 85736

Reason for Recall:

Roi CPS, LLC has become aware of a labeling error that affects select custom procedure kits. The kits are labeled with an expiration date that is later than that of the soonest kit component to expire in the kits.

Status: Terminated

Product Quantity: 24 kits

Code Information:

Item: 830006013, Lot #: 78253M

Distribution Pattern:

Domestic distribution only to: MO and LA.

Voluntary or Mandated:

Voluntary: Firm initiated