Z-0012-2020Class II

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

Name: Z-0012-2020 Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Creator: Inter-Med Llc
Published: 2019-06-27
License: https://open.fda.gov/license/

Inter-Med, Inc. / initiated 2019-06-27 / Terminated / root cause: manufacturing process

FDA source

Inter-Med Llc began a recall of Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300 on 2019-06-27. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0012-2020
Classification: Class II
Status: Terminated
Initiated: 2019-06-27
Posted: 2019-10-01
Terminated: 2021-08-10
Recalling firm: Inter-Med, Inc.
Product: Vista Dental Products Sodium Hypochlorite - 6%, 10 - 12cc Pre-filled Syringes, REF 502300
Product code: KJJ Cleanser, Root Canal
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm initiated the recall by letter on 06/27/2019. The letter directed the consignee to quarantine the product and contact the returns department for return instructions.
Quantity in commerce: 1992 units
Distribution: US, South Africa, Switzerland, Poland, Italy, Singapore, Australia
Product codes and lots: Lot/Work Order Numbers: 2018-1348 2018-1585 2018-1586 2018-1852 20182106, UDI (01)10818207020465 20182302, UDI (01)10818207020465 20182458, UDI (01)10818207020465 20190725, UDI (01)10818207020465 20190835, UDI (01)10818207020465

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0012-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0011-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0012-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0013-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0014-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0015-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0016-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01
Z-0017-2020	Class II	Terminated	Voluntary: Firm initiated	2019-10-09	2019-10-01

Product code KJJ

K082470UnclassifiedSodium Hypochlorite 3 & 6% Solution and 6% with Wetting Agents to Lower Surface Tension Marketed as Chlor-XtraInter-Med, Inc. / cleared 2009-04-03

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)