FDA recall Z-0195-2023

Avanos Medical, Inc. · Class II · device

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 for recall

Sterile extension sets were distributed without an expiration date

Distribution

US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI

Key facts

Status
Terminated
Initiation date
2022-09-14
Report date
2022-11-16
Termination date
2023-08-31
Voluntary/Mandated
Voluntary: Firm initiated
Location
Alpharetta, GA, United States

Primary source

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