Class II — Avanos Medical, Inc.
| Recalling firm | Avanos Medical, Inc. |
|---|---|
| Registered facility | View this company's 3 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | Sterile extension sets were distributed without an expiration date |
| Product | Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUMMIT MEDICAL PRODUCTS, REF 220227; MPS Acacia CAT NO: BC-006-04; MEDICAL PRODUCTS SPECIALISTS EXTENSION SET, Catalog Number BC00604, pain control pump accessory |
| Quantity | 1378 units |
| Distribution | US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI |
| Initiated | 2022-09-14 |
| Classified | 2022-11-07 |
| Terminated | 2023-08-31 |
| Recall number | Z-0195-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Avanos Medical, Inc. (Z-0195-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/90964/
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