Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-3087-2024 — smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows: 1) BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY), Item Number 101/540/080; 2) BLUgriggs Percutaneous Dilati

U.S. FDA — Device Enforcement · United States · 2024-06-07 · Class I

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-3087-2024
Date of alert: 2024-06-07
Country / jurisdiction: United States
Risk level: Class I
Risk type: recall
Brand: Smiths Medical ASD Inc.
Product category: device
Product type: Devices

Reported risk: There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

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