Y-CONNECTOR: 6" Small Kink Resistant Tubing Bifurcated Connector /2 Male Luer Locks, 1 Female Luer Lock, Labeled as: SUM

FDA device recall Z-0195-2023 · posted 2022-11-08 · Terminated

Recall details

Recalling firm

Avanos Medical, Inc.

Reason for recall

Sterile extension sets were distributed without an expiration date

Action taken

AVANOS sent an URGENT: FIELD CORRECTION on 09/15/2022 via overnight FedEx to customers. The letter explained the issue and requested the following: "WHAT SHOULD I DO IN RESPONSE TO THIS FIELD CORRECTION? Our records show that you and/or your facility have received one or more of the impacted products. Avanos requests that you take the following actions: " CHECK all storage and usage locations to determine if any impacted product remains within your possession and QUARANTINE all impacted product identified. " COMPLETE and RETURN the attached Acknowledgement Form (Attachment 1) to Avanos. o Via email to fieldactioncare@avanos.com , subject line FCA-2022-007 Hospital Acknowledgement Form o Avanos Customer Service will contact you regarding product return Please respond within five (5) business days of receipt of this letter. If you have questions or require further assistance, please contact Avanos via email at fieldactioncare@avanos.com." The firm sent updated letters the week of October 10, 2022. The letters titled, "URGENT: PRODUCT RECALL" provided updated product descriptions.

Root cause

Incorrect or no expiration date

Status

Terminated

Product code

FPA

Quantity affected

1378 units

Distribution

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

Date initiated

2022-09-14

Date posted

2022-11-08

Date terminated

2023-08-31

Location

Alpharetta, GA