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
This recall has been terminated (originally issued November 8, 2022).
- Company
- Avanos Medical, Inc.
- Recall Initiated
- September 14, 2022
- Posted
- November 8, 2022
- Terminated
- August 31, 2023
- Recall Number
- Z-0195-2023
- Quantity
- 1378 units
- Firm Location
- Alpharetta, GA
- Official Source
- View on FDA website ↗
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
Lot / Code Info
ALL LOT CODES
Root Cause
Incorrect or no 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.