Reported Sep 18, 2024 · Ongoing
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as…
Smiths Medical ASD Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Smiths Medical ASD Inc. · 6000 Nathan Ln N · Minneapolis, MN · 55442-1690
Is this the product you have?
smiths medical portex BLUperc Percutaneous Diliation Procedural Trays with BLUselect tracheostomy tubes, labeled as follows
12 of 12 products
| Model / number | Product as published |
|---|---|
101/561/070 | BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect trach tube |
101/561/080 | BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect trach tube |
101/561/090 | BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect trach tube |
101/563/070 | BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube |
101/563/080 | BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube |
101/563/090 | BLUperc Percutaneous Dilation Procedural Kit with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube |
101/595/070 | BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect trach tube (drugs, US ONLY) |
101/595/080 | BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect trach tube (drugs, US ONLY) |
101/595/090 | BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect trach tube (drugs, US ONLY) |
101/596/070 | BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 7.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
101/596/080 | BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 8.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
101/596/090 | BLUperc Percutaneous Dilation Procedural Tray with Single Stage Dilator and 9.0 mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
- Lot codes and dates
309 of 309 products
Products covered by this recall # Product as published 1 Lot Number 3887555; 101/561/070 2 Lot Number 3928959; 101/561/070 3 Lot Number 4005346; 101/561/070 4 Lot Number 4217858; 101/561/070 5 Lot Number 4234862; 101/561/070 6 Lot Number 4266405; 101/561/070 7 Lot Number 4348810; 101/561/080 8 Lot Number 3887536; 101/561/080 9 Lot Number 3906566; 101/561/080 10 Lot Number 3906567; 101/561/080 11 Lot Number 3906568; 101/561/080 12 Lot Number 4217859; 101/561/080 13 Lot Number 4232677; 101/561/080 14 Lot Number 4238252; 101/561/080 15 Lot Number 4249230; 101/561/080 16 Lot Number 4281149; 101/561/080 17 Lot Number 4281150; 101/561/080 18 Lot Number 4283700; 101/561/080 19 Lot Number 4285877; 101/561/080 20 Lot Number 4288974; 101/561/080 - Amount recalled
- 41691 units
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Why it was recalled
Stop using this product now
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.
Using this product could cause serious injury, illness or death — stop using it now.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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