Inter-Med Llc: Medical Device Recall in 2019 - (Recall #: Z-0013-2020)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2019.

Data Source: FDA.

Product Description:

Vista Dental Products Sodium Hypochlorite - 3%, 10 - 12cc Pre-filled Syringes, REF 502315

Product Classification:

Class II

Date Initiated: June 27, 2019

Date Posted: October 9, 2019

Recall Number: Z-0013-2020

Event ID: 83435

Reason for Recall:

The affected lots may be packaged in syringes which include an incorrect bung. The incorrect bung is made of a latex-free isoprene rubber material. After prolonged storage and exposure to contained solutions, the rubber bung may degrade due to chemical interaction with the bleach solution.

Status: Terminated

Product Quantity: 582 units

Code Information:

Lot/Work Order Numbers: 2018-1349 2018-1587 2018-1853 20182107, UDI (01)10818207020427 20182303, UDI (01)10818207020427 20182584, UDI (01)10818207020427 20182666, UDI (01)10818207020427 20190199, UDI (01)10818207020427 20190433, UDI (01)10818207020427

Distribution Pattern:

US, South Africa, Switzerland, Poland, Italy, Singapore, Australia

Voluntary or Mandated:

Voluntary: Firm initiated