FDA Device Intelligence
HomePeter Brasseler Holdings, LLC › BC Sealer

BC Sealer

Peter Brasseler Holdings, LLC · Model 5031698U0 · UDI-DI 08404535011982

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

Description

BC SEALER SOLVENT 8OZ

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.