FDA Device Recall Z-0013-2020: Inter-Med Llc

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0013-2020.

Recall Res Number

Z-0013-2020

Recalling Firm / Manufacturer

Inter-Med Llc

FEI Number

3000209941

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2019-06-27

Date Posted

2019-10-01

Date Terminated

2021-08-10

Product Code

KJJ

Event Number

83435

Product Quantity

582 units

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

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.

Action Details 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.

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

Code Information / Serial Numbers 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

Related Establishments / Registrations

BRASSELER U.S.A. DENTAL, LLC Registration: 1032227 View Registration
BICON, LLC Registration: 1223843 View Registration
DENTAL TECHNOLOGIES, INC. Registration: 1413475 View Registration
Ultradent Products Inc. Registration: 1718912 View Registration
YOUNG DENTAL MANUFACTURING CO 1, LLC. Registration: 1941138 View Registration
Sterigenics Radiation Technologies, LLC Registration: 2024024 View Registration
Kerr Corporation Registration: 2024312 View Registration
YOUNG INNOVATIONS INC. Registration: 2024980 View Registration
PAC-DENT INC. Registration: 2086043 View Registration
INTER-MED, INC. Registration: 2133714 View Registration
Sterigenics U.S., LLC Registration: 2245590 View Registration
TULSA DENTAL PRODUCTS LLC Registration: 2320721 View Registration
COLTENE/WHALEDENT INC. Registration: 2416455 View Registration
ESSENTIAL DENTAL SYSTEMS, INC. Registration: 2433629 View Registration
CARGUS INT'L, INC. Registration: 2437780 View Registration
PREMIER DENTAL PRODUCTS CO. Registration: 2511556 View Registration
DENTSPLY LLC Registration: 2515379 View Registration
EPIEN MEDICAL, INC. Registration: 3003428492 View Registration
Sonoma Pharmaceuticals, Inc. Registration: 3004554409 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
NUSMILE, LTD Registration: 3006444232 View Registration
Oculus Technologies of Mexico, S.A de C.V. Registration: 3007244484 View Registration
ELEVATE ORAL CARE, LLC Registration: 3009603151 View Registration
3D DENTAL DESINGS AND DEVELOPMENT Registration: 3010864832 View Registration
JERSEY DENTAL SUPPLIES Registration: 3012187973 View Registration
MAINLINE MEDICAL DENTAL SUPPLY Registration: 3012421607 View Registration
Kerr Corporation Registration: 3012477813 View Registration
JORDCO, INC. Registration: 3026760 View Registration
ENDO DIRECT, LLC Registration: 3027344570 View Registration
SILGAN UNICEP PACKAGING, LLC. Registration: 3028011 View Registration
OKETZ LOGISTICS LLC Registration: 3038718579 View Registration
HSG-S CORP Registration: 3042866301 View Registration
BIORA AB Registration: 9612827 View Registration
INSTITUT STRAUMANN AG Registration: 9613348 View Registration
SDS de Mexico S. de R.L. de C.V. Registration: 9680845 View Registration

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0013-2020

Recall Parameters & Description

Related Establishments / Registrations

Public Record Disclaimer