FDA Device Intelligence
Home › BENCO DENTAL SUPPLY CO. › GIBSON HEALTHCARE

GIBSON HEALTHCARE

BENCO DENTAL SUPPLY CO. · Model 5126-301 · UDI-DI 00366975032812

KJJ Prescription
10
510(k) clearances
24
Adverse events
7
Recalls
35
Facilities

Description

Gibson Healthcare Endo Irrigation Single Canal Kit. Contains: (1) 10ml pre-filled sodium hypochlorite syringe, (1) 3ml pre-filled EDTA syringe, (1) 3ml pre-filled 95% ethyl alcohol syringe, (1) 3ml pre-filled chlorhexidine syringe, (4) 30g irrigation needle tips, (1) canal aspiratior with tip.

Recalls

DateFirmReason
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex
2019-06-27Inter-Med LlcThe 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 ex

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.