Recall Z-0195-2023 ยท FPA Set, Administration, Intravascular
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
| Date | Nov 8, 2022 (initiated Sep 14, 2022) |
| Status | Terminated |
| 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 |
| Quantity | 1378 units |
| Distribution | US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.