Reported Sep 18, 2024 · Ongoing
smiths medical portex BLUselect, tracheostomy tube, labeled as follows
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 BLUselect, tracheostomy tube, labeled as follows
53 of 53 products
| Model / number | Product as published |
|---|---|
101/800/060CZ | BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX |
101/800/070CZ | BLUSELECT 7.0, CUFFED, NON-FEN, 10/BX |
101/800/075CZ | BLUSELECT 7.5, CUFFED, NON-FEN, 10/BX |
101/800/080CZ | BLUSELECT 8.0, CUFFED, NON-FEN, 10/BX |
101/800/085CZ | BLUSELECT 8.5, CUFFED, NON-FEN, 10/BX |
101/800/090CZ | BLUSELECT 9.0, CUFFED, NON-FEN, 10/BX |
101/800/100CZ | BLUSELECT 10.0, CUFFED, NON-FEN, 10/BX |
101/802/060CZ | BLUSELECT 6.0, CUFFED, FEN, 10/BX |
101/802/070CZ | BLUSELECT 7.0, CUFFED, FEN, 10/BX |
101/802/075CZ | BLUSELECT 7.5, CUFFED, FEN, 10/BX |
101/802/080CZ | BLUSELECT 8.0, CUFFED, FEN, 10/BX |
101/802/085CZ | BLUSELECT 8.5, CUFFED, FEN, 10/BX |
101/802/090CZ | BLUSELECT 9.0, CUFFED, FEN, 10/BX |
101/802/100CZ | BLUSELECT 10.0, CUFFED, FEN, 10/BX |
101/810/060CZ | BLUSELECT 6.0, CUFFED, NON-FEN, 1/EA |
101/810/070CZ | BLUSELECT 7.0, CUFFED, NON-FEN, 1/EA |
101/810/075 | BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA |
101/810/075CZ | BLUSELECT 7.5, CUFFED, NON-FEN, 1/EA |
101/810/080 | BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA |
101/810/080CZ | BLUSELECT 8.0, CUFFED, NON-FEN, 1/EA |
- Lot codes and dates
842 of 842 products
Products covered by this recall # Product as published 1 Lot Number 3895097; 101/800/060CZ 2 Lot Number 3925835; 101/800/060CZ 3 Lot Number 4025600; 101/800/060CZ 4 Lot Number 4106716; 101/800/060CZ 5 Lot Number 4230149; 101/800/060CZ 6 Lot Number 4252500; 101/800/060CZ 7 Lot Number 4382002; 101/800/070CZ 8 Lot Number 3895101; 101/800/070CZ 9 Lot Number 3925960; 101/800/070CZ 10 Lot Number 3933088; 101/800/070CZ 11 Lot Number 4010050; 101/800/070CZ 12 Lot Number 4022790; 101/800/070CZ 13 Lot Number 4034826; 101/800/070CZ 14 Lot Number 4037975; 101/800/070CZ 15 Lot Number 4133612; 101/800/070CZ 16 Lot Number 4152440; 101/800/070CZ 17 Lot Number 4156971; 101/800/070CZ 18 Lot Number 4217804; 101/800/070CZ 19 Lot Number 4238237; 101/800/070CZ 20 Lot Number 4249341; 101/800/070CZ - Amount recalled
- 799732 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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