Spes Medica: Medical Device Recall in 2021 - (Recall #: Z-1968-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

SNS Disposable Urethral Catheter Electrode, 10 Fr, Gold Recording/Stimulating Contact printed on polyurethane film adhesive with attached 2 meter lead-wire with touch-proof connector, Reference Number UE006

Product Classification:

Class II

Date Initiated: April 8, 2021

Date Posted: July 7, 2021

Recall Number: Z-1968-2021

Event ID: 87999

Reason for Recall:

The supplier informed them of possible deviations of the parameters/processes defined for ethylene oxide sterilization.

Status: Terminated

Product Quantity: 34 boxes

Code Information:

Lot UR20F2702I

Distribution Pattern:

Distribution in the following US states: CA, MA, and SC.

Voluntary or Mandated:

Voluntary: Firm initiated