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U.S. Department of Health and Human Services

Class 2 Device Recall YConnector

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  Class 2 Device Recall YConnector see related information
Date Initiated by Firm September 14, 2022
Date Posted November 08, 2022
Recall Status1 Terminated 3 on August 31, 2023
Recall Number Z-0195-2023
Recall Event ID 90964
Product Classification Set, administration, intravascular - Product Code FPA
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
Code Information ALL LOT CODES
Recalling Firm/
Manufacturer		 Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact Lisa Clark
470-448-5591
Manufacturer Reason
for Recall		 Sterile extension sets were distributed without an expiration date
FDA Determined
Cause 2		 Incorrect or no expiration date
Action 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.
Quantity in Commerce 1378 units
Distribution US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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