FDA Medical Device Recalls (openFDA)
Avanos Medical, Inc.: 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
- Recall number
- Z-0195-2023
- Recalling firm
- Avanos Medical, Inc.
- 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
- Status
- Terminated
- Initiated
- 2022-09-14
- Posted
- 2022-11-08
- Terminated
- 2023-08-31
- Reason
- Sterile extension sets were distributed without an expiration date
- Root cause
- 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
- 1378 units
- Distribution
- US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
- Lot, serial or model codes
- ALL LOT CODES
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- FPA
- Firm FEI
- 3011270181
- Firm city
- Alpharetta
- Firm state
- GA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28