Blue Rhino G57721Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00827002577213), received between Oct 17, 2024 and Oct 17, 2024 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

3 other recalls cover devices cleared under the same FDA submission (K193133); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Apr 7, 2023Class IOpen, Classified

   There were reports from customers that the tracheostomy in the sets and trays is not making a secure connection with the 15mm cap and other 15mm circuit components and accessories. This resulted in an unsecure connection between the device connector and circuit components, cap, or accessories.

   Z-1428-2023 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024Break; Break

  ADDITIONAL INFORMATION WAS PROVIDED (B)(6) 2024. THE PRODUCT REGARDING THIS COMPLAINT DID COME INTO CONTACT WITH THE PATIENT. PATIENT INFORMATION WAS NOT ABLE TO BE PROVIDED. THE PATIENT¿S CONDITION FOR REQUIRING TREATMENT WAS UNKNOWN. THE PROCEDURE WAS COMPLETED BY USING ANOTHER LIKE CLAMP DEVICE THE PATIENT DID NOT REQUIRE ANY ADDITIONAL INTERVENTIONS/PROCEDURES NOR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS EVENT.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20472784 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K193133. One submission often covers many models, so check the product and lot details in each record.

• Z-1779-2026 · Mar 5, 2026 · Open, Classified
  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; Reference Part Number C-PTIS-100-HC-G-NA
• Z-1780-2026 · Mar 5, 2026 · Open, Classified
  COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703; Reference Part Number C-PTISY-100-UNL-
• Z-1427-2023 · Apr 7, 2023 · Open, Classified
  Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set, Reference Part Numbers C-PTIS-100-HC-G-EU-FLEX7.5 (G57695), C-PTIS-100-HC-G-EU-FLEX8.5 (G57696), C-PTIS-100-HC-G-NA-FL