Z-0195-2023 Class II Terminated
FDA device recall Z-0195-2023 was initiated by Avanos Medical, Inc. on Sep 14, 2022 and is designated Class II. Reason for recall: Sterile extension sets were distributed without an expiration date The recall status is terminated (terminated Aug 31, 2023). Affected quantity: 1378 units.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 16, 2022
- Initiation Date
- Sep 14, 2022
- Termination Date
- Aug 31, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1378 units
Product Description
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
Reason for Recall
Sterile extension sets were distributed without an expiration date
Distribution Pattern
US: CA, CO, FL, MI, NM, OH, OR, TN, TX, UT, WI
Code Information
ALL LOT CODES
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0195-2023
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 24, 2026