FDA-Device2022-11-16Class II

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

Avanos Medical, Inc.
Hazard

Sterile extension sets were distributed without an expiration date

Sold states
US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
Affected count
1378 units
Manufactured in
5405 Windward Pkwy, N/A, Alpharetta, GA, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0195-2023

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