Pompano Beach, FL, United States
International Medical Industries, Inc. recalls
1 recall recorded since 2018, most recently on 16 September 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 16 September 2022
- Reason
- Blister package had an unsealed edge compromising sterility.
- Distribution
- US Nationwide Distribution was made to AR, AZ, CA, CO, FL, GA, ID, IL, IN, IA, KS, KY, MD, MA, MI, MS, MO, MT, NE, NJ, NY, NC, OH, PA, SC, TX, and VA. There was no government/military/foreign distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0925-2023
- Prep-Fill Guarded Luer Connector (GLC): a. Part Number 57-400, Female Lock - Female Lock Guarded Luer Connector, Sterile; b. Part number 57-400W, Female Lock - Female Lock Guarded Luer Connector, Sterile; c.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.