Reported Apr 25, 2018 · Terminated
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a…
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?
Halyard Closed Suction System for Adults, Double Swivel Elbow (DSE). Used to aspirate liquids or semisolids from a patient's upper airway. Labeled as the following
19 of 19 products
| # | Product as published |
|---|---|
| 1 | HALYARD* 12FR DSE 21.3IN/54CM (WHITE) |
| 2 | HALYARD* 12 FR TRACH CARE DSE ENDO |
| 3 | HALYARD* 12FR DSE 12IN/30.5CM (WHITE) |
| 4 | HALYARD* 12FR TRACH CARE DSE TRACH |
| 5 | HALYARD* 14FR DSE 21.3IN/54CM (GREEN) |
| 6 | HALYARD* 14FR TRACH CARE DSE ENDO |
| 7 | HALYARD* 14FR DSE 12IN/30.5CM (GREEN) |
| 8 | HALYARD* 14FR TRACH CARE DSE TRACH |
| 9 | HALYARD* 14FR DSE 12IN/30.5CM |
| 10 | HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH |
| 11 | HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO |
| 12 | HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO |
| 13 | HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO |
| 14 | HALYARD* 14FR TRACH CARE DSE MDI ENDO |
| 15 | HALYARD* 14FR DSE 22.2IN/56 CM (GREEN) |
| 16 | HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO |
| 17 | HALYARD* 16FR DSE 21.3IN/54CM (ORANGE) |
| 18 | HALYARD* 16FR TRACH CARE DSE ENDO |
| 19 | HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO |
- Lot codes and dates
19 of 19 products
Products covered by this recall # Product as published 1 HALYARD* 12FR DSE 21.3IN/54CM (WHITE), (2160) 2 HALYARD* 12 FR TRACH CARE DSE ENDO, (2160-5) 3 HALYARD* 12FR DSE 12IN/30.5CM (WHITE), (21603) 4 HALYARD* 12FR TRACH CARE DSE TRACH, (21603-5) 5 HALYARD* 14FR DSE 21.3IN/54CM (GREEN), (22108130, 2210, 22106, 22107, 22108, 22108147, 8224) 6 HALYARD* 14FR TRACH CARE DSE ENDO, (2210-5) 7 HALYARD* 14FR DSE 12IN/30.5CM (GREEN), (22103, 221037, 221038, 8223, 221036) 8 HALYARD* 14FR TRACH CARE DSE TRACH, (22103-5) 9 HALYARD* 14FR DSE 12IN/30.5CM, (221036-5) 10 HALYARD* 14FR TRACH CARE WET PAK* DSE MDI TRACH, (2210386-5) 11 HALYARD* 14FR TRACH CARE WET PAK* DSE ENDO, (22106-5) 12 HALYARD* 14FR TRACH CARE WET PAK* DSE DIR TIP ENDO, (221069-5) 13 HALYARD* 14 FR TRACH CARE DSE DUAL LUMEN ENDO, (22107-5) 14 HALYARD* 14FR TRACH CARE DSE MDI ENDO, (22108-5) 15 HALYARD* 14FR DSE 22.2IN/56 CM (GREEN), (22108148, 22109) 16 HALYARD* 14FR TRACH CARE DSE DIR TIP ENDO, (22109-5) 17 HALYARD* 16FR DSE 21.3IN/54CM (ORANGE), (2260, 22606) 18 HALYARD* 16FR TRACH CARE DSE ENDO, (2260-5) 19 HALYARD* 16FR TRACH CARE WET PAK* DSE ENDO, (22606-5) - 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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