Agency classClass IOur severity:Severe FDA (Devices)·Z-3087-2024·Announced 2024-09-18

Smiths Medical Tracheotomy Tube Kits Recalled for Pilot Balloon Disconnection

Smiths Medical is recalling approximately 12,234 BLUselect, BLUgriggs, and BLUperc tracheotomy tube kits due to a manufacturing defect that may cause the pilot balloon to disconnect from the inflation line.

The agency’s classification

FDA (Devices): Class I

Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I medical device recall. Per the severity rubric, FDA Class I recalls never score below 4. The manufacturing defect in tracheostomy tube equipment poses a serious potential risk to patient airway management.

Plain-English summary

Smiths Medical ASD Inc. is recalling multiple models of BLUselect, BLUgriggs, and BLUperc percutaneous dilation procedural trays and kits with tracheotomy tubes. Approximately 12,234 units have been distributed worldwide across 17 different product configurations and multiple lot numbers.

The recall is due to a manufacturing defect that may cause disconnection of the pilot balloon from the tracheostomy inflation line. The affected products are identified by item number and specific lot numbers.

Healthcare providers using affected products should stop use immediately and contact Smiths Medical for replacements. Patients who may be using affected units should consult their healthcare provider. The FDA has classified this as a Class I recall, its highest severity category for medical devices.

The recalled product

Product: 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)…
Manufacturer: Smiths Medical ASD Inc.
Category: Medical Device — Tracheostomy Tubes / Airway Management
Hazard: equipment-disconnection
manufacturing-defect
Affected units: 12,234

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

101/540/080
Lot Number 3943992
Lot Number 4258998
101/540/090
Lot Number 4309778
101/541/070
Lot Number 3887542
Lot Number 3913366
Lot Number 4202486
Lot Number 4350937
101/541/080
Lot Number 3887517
Lot Number 3910324
Lot Number 3912758
Lot Number 4170885
Lot Number 4184037
Lot Number 4310310
Lot Number 4312324
Lot Number 4332049
Lot Number 4332050

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 3 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

Same manufacturer · Smiths Medical ASD Inc.

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