Recall Z-1387-2018— Preservation Solutions, Inc.
Class II · Terminated
Class II FDA medical device recall by Preservation Solutions, Inc., initiated 2018-02-26, terminated 2022-09-09. It names one FDA 510(k) clearance: K073693. Product: 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 specific organs in preparation for storage, transportation, and transplantation into a recipient.. 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...
- Recalling firm
- Preservation Solutions, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-02-26
- Terminated
- 2022-09-09
- Firm location
- Elkhorn, WI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 specific organs in preparation for storage, transportation, and transplantation into a recipient.
Reason for recall
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..
Data sourced from openFDA. This site is unofficial and independent of the FDA.