Reported Sep 18, 2024 · Ongoing
smiths medical portex BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy 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 BLUgriggs Percutaneous Dilation Procedural Trays with BLUselect tracheotomy tubes, labeled as follows
17 of 17 products
| Model / number | Product as published |
|---|---|
101/540/080 | BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect trach tube (drugs, US ONLY) |
101/540/090 | BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect trach tube (drugs, US ONLY) |
101/541/070 | BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect trach tube |
101/541/080 | BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect trach tube |
101/541/090 | BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect trach tube |
101/543/070 | BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect trach tube, no forceps |
101/543/080 | BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect trach tube, no forceps |
101/543/090 | BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect trach tube, no forceps |
101/891/070 | BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 7.0mm BLUselect SuctionAid trach tube |
101/891/080 | BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 8.0mm BLUselect SuctionAid trach tube |
101/891/090 | BLUgriggs Percutaneous Dilation Procedural Kit with forceps and 9.0mm BLUselect SuctionAid trach tube |
101/892/070 | BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 7.0mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
101/892/080 | BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 8.0mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
101/892/090 | BLUgriggs Percutaneous Dilation Procedural Tray with forceps and 9.0mm BLUselect SuctionAid trach tube (drugs, US ONLY) |
101/893/070 | BLUgriggs Percutaneous Dilation Procedural Kit with 7.0mm BLUselect SuctionAid trach tube, no forceps |
101/893/080 | BLUgriggs Percutaneous Dilation Procedural Kit with 8.0mm BLUselect SuctionAid trach tube, no forceps |
101/893/090 | BLUgriggs Percutaneous Dilation Procedural Kit with 9.0mm BLUselect SuctionAid trach tube, no forceps |
- Lot codes and dates
102 of 102 products
Products covered by this recall # Product as published 1 Lot Number 3943992; 101/540/080 2 Lot Number 4258998; 101/540/090 3 Lot Number 4309778; 101/541/070 4 Lot Number 3887542; 101/541/070 5 Lot Number 3913366; 101/541/070 6 Lot Number 4202486; 101/541/070 7 Lot Number 4350937; 101/541/080 8 Lot Number 3887517; 101/541/080 9 Lot Number 3910324; 101/541/080 10 Lot Number 3912758; 101/541/080 11 Lot Number 4170885; 101/541/080 12 Lot Number 4184037; 101/541/080 13 Lot Number 4310310; 101/541/080 14 Lot Number 4312324; 101/541/080 15 Lot Number 4332049; 101/541/080 16 Lot Number 4332050; 101/541/090 17 Lot Number 3887526; 101/541/090 18 Lot Number 3925818; 101/541/090 19 Lot Number 4234865; 101/541/090 20 Lot Number 4266477; 101/541/090 - Amount recalled
- 12234 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.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Smiths Medical ASD Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.