Elkhorn, WI, United States
Preservation Solutions, Inc. recalls
1 recall recorded since 2018, most recently on 26 February 2018. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 26 February 2018
- Terminated
- 9 September 2022
- Reason
- Bags of solution may have a small leak at the base of the injection port where the port is welded into the body of the bag..
- Distribution
- Worldwide Distribution -- USA and Europe.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1387-2018
- Cold Storage Solution, 2L, labeled as Waters IGL Cold Storage Solution, Catalog No. CSS/2000/US; and, Belzer UW Cold Storage Solution, Catalog No. BUW_002. Intended for the hypothermic flushing and storage of specifi
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.