Recall Z-0012-2020— Inter-Med Llc

Name: FDA recall Z-0012-2020
Creator: U.S. Food and Drug Administration
Published: 2019-06-27

Class II · Terminated

Class II FDA medical device recall by Inter-Med Llc, initiated 2019-06-27, terminated 2021-08-10. It names one FDA 510(k) clearance: K082470. Product: Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300. Reason: 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..

Recalling firm: Inter-Med Llc
Classification: Class II
Status: Terminated
Initiated: 2019-06-27
Terminated: 2021-08-10
Firm location: Racine, WI, United States

510(k) clearances named in this recall

1 on FDA's record

K082470 — SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRAInter-Med, Inc.·cleared 2009-04-03

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.