Reported Apr 25, 2018 · Terminated
Halyard Closed Suction System for Adults, Turbo- cleaning¿Closed¿Suction¿System¿for¿Adults,¿Double¿Swivel¿Elbow (DSE).…
Halyard Health, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.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: Halyard Health, Inc · 5405 Windward Pkwy · Alpharetta, GA · 30004-3894
Is this the product you have?
26 of 26 products
| # | Product as published |
|---|---|
| 1 | HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN) |
| 2 | HALYARD* TRACH CARE-72 DSE ENDO 14FR |
| 3 | HALYARD* TRACH CARE-72 WET PAK* 14FR |
| 4 | HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR |
| 5 | HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN) |
| 6 | HALYARD* TRACH CARE-72 DSE TRACH 14FR |
| 7 | HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR |
| 8 | HALYARD* TRACH CARE-72 DSE ENDO 10FR |
| 9 | HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK) |
| 10 | HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR |
| 11 | HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR |
| 12 | HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE) |
| 13 | HALYARD* 72 DSE MDI BUILT IN ENDO 12FR |
| 14 | HALYARD* 72 DSE TRACH CARE 12FR |
| 15 | HALYARD* 14FR DSE 22.2IN/56CM (GREEN) |
| 16 | HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR |
| 17 | HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN) |
| 18 | HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR |
| 19 | HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR |
| 20 | HALYARD* TC-72 WET PAK DSE MDI ENDO 14FR |
- Lot codes and dates
27 of 27 products
Products covered by this recall # Product as published 1 HALYARD* TURBO-CLEANING 14FR DSE 21.3IN/54 CM (GREEN), 227 2 HALYARD* TRACH CARE-72 DSE ENDO 14FR, 227-5 3 HALYARD* TRACH CARE-72 WET PAK* 14FR, 22701356-5 4 HALYARD* TRACH CARE-72 WET PAK* T-PIECE SWVL/FLEX ENDO 14FR, 2270156-5 5 HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5 CM (GREEN), 22703 6 HALYARD* TRACH CARE-72 DSE TRACH 14FR, 22703-5 7 HALYARD* TRACH CARE-72 WET PAK* DSE TRACH 14FR, 227036-5 8 HALYARD* TRACH CARE-72 DSE ENDO 10FR, 227101-5 9 HALYARD* TURBO-CLEANING 10FR DSE 12IN/30.5CM (BLACK), 2271013 10 HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 10FR, 2271018-5 11 HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 12FR, 2271218-5 12 HALYARD* TURBO-CLEANING 12FR DSE 12IN/30.5CM (WHITE), 22712183 13 HALYARD* 72 DSE MDI BUILT IN ENDO 12FR, 22712186-5 14 HALYARD* 72 DSE TRACH CARE 12FR, 227121863-5 15 HALYARD* 14FR DSE 22.2IN/56CM (GREEN), 2271418 16 HALYARD* TRACH CARE-72 DSE MDI BUILT IN ENDO 14FR, 2271418-5 17 HALYARD* TURBO-CLEANING 14FR DSE 12IN/30.5CM (GREEN), 22714183 18 HALYARD* TRACH CARE-72 DSE MDI BUILT IN TRACH 14FR 19 22714183-5 20 HALYARD* TC-72 WET PAK* DSE MDI ENDO 14FR, 22714186 - Amount recalled
- 32,189 cases (20 units per case - 643,780 units) total
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
- PR
Why it was recalled
Certain Flex Connectors supplied with Halyard Closed Suction Kits with Flex Connector may become loose or disconnect before use or during use.
This product could cause temporary or reversible health problems — stop using it.
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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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