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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Halyard Health, Inc: Received recall notification from Smiths Medical that lots of 15ml Saline Vials may be susceptible to leaking and could potentially result in the exposure of the saline contents to infectious agents.

Agency Publication Date: November 18, 2017
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Affected Products

Product: Halyard Closed Suction System for Adults with BALLARD Technology WET PAK. 12 saline vials per kit, 20 kits per case.

Product Code 2216 with Lot AB6032U03; Product Code 22056 with Lot AB6032U12; Product Code 220569 with Lot AB6207U11

Lot Numbers:
2216
AB6032U03
22056
AB6032U12
220569
AB6207U11
Product: Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 saline vials per kit, 20 kits per case.

Product Code 2276, Lots AB6018U03, AB6137U12, AB6305U17.

Lot Numbers:
2276
Product: Halyard Closed Suction System for Adults, 14 F, DSE, Wet Pak. 12 or 6 vials per kit, 20 kits per case.

Product Code 22106 with Lots AB6011U20, AB6123U07 AB6123U01, AB3207U04, AB6284U17; Product Code 221036 with Lot AB6263U11; Product Code 22108147 with Lots AB6011U15, AB6067U17, AB6256U13

Lot Numbers:
22106
221036
AB6263U11
22108147
Product: Halyard Closed Suction System for Adults, 14 F, Elbow, Directional Tip, Wet Pak. 12 vials per kit, 20 kits per case.

Product Code 22169, Lots AB6123U08, AB6123U11

Lot Numbers:
22169
Product: Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 vials per kit, 20 kits per case.

Product Code 227056 with Lots AB6123U12, AB6284U18; Product Code 22701356 with Lot AB6207U12

Lot Numbers:
227056
22701356
AB6207U12
Product: Halyard Closed Suction System for Adults, 14 F, T-Piece, Wet Pak. 12 or 6 vials per kit, 20 kits per case.

Product Code 22012356 with Lot AB6032U10; Product Code 2208A055 with Lot AB6291U17

Lot Numbers:
22012356
AB6032U10
2208A055
AB6291U17
Product: Halyard Turbo-Cleaning Closed Suction System for Adults, 14 F, DSE, MDI, Wet Pak. 12 vials per kit, 20 kits per case.

Product Code 22714186 with Lot AB6088U01

Lot Numbers:
22714186
AB6088U01
Product: Halyard Closed Suction System for Adults, 14 F, T-Piece, MDI, Wet Pak. 12 vials per kit, 20 kits per case.

Product Code 220123568 with Lot AB6151U08, AB6207U13

Lot Numbers:
220123568
AB6151U08
Product: NOVAPLUS* Endotracheal WET PAK* Closed Suction System for Adults with BALLARD* Technology, Double Swivel Elbow, 14 F. 6 vials per kit, 20 kits per case.

Product Code 2V22108147 with Lot AB6018U07

Lot Numbers:
2V22108147
AB6018U07

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78391
Status: Resolved
Manufacturer: Halyard Health, Inc
Manufactured In: United States
Units Affected: 9 products (52,660 kits (2,633 cases) with 631,920 saline vials)

Were You Affected by This Recall?

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.