Recall Z-0195-2023— Avanos Medical, Inc.

Name: FDA recall Z-0195-2023
Creator: U.S. Food and Drug Administration
Published: 2022-09-14

Class II · Terminated

Class II FDA medical device recall by Avanos Medical, Inc., initiated 2022-09-14, terminated 2023-08-31. FDA's recall record names no specific 510(k) clearance for this event. 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. Reason: Sterile extension sets were distributed without an expiration date.

Recalling firm: Avanos Medical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2022-09-14
Terminated: 2023-08-31
Firm location: Alpharetta, GA, United States

Product description

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

Reason for recall

Sterile extension sets were distributed without an expiration date

Data sourced from openFDA. This site is unofficial and independent of the FDA.