Bridge to Life Ltd. and Waters Medical Systems have issued a field correction for specified lots of Belzer UW Cold Storage Solution and IGL Cold Storage Solution in 2-liter bags. Under the terms of a “field correction,” if an inspection by qualified personnel does not identify a defect, the product may be returned for use. Also, please note that 1-liter solution bags are not subject to this notice.
The solution manufacturer has identified two units of product in the affected lots to have a pinhole leak in the storage bag. Such a leak, if present, compromises sterility and could lead to contamination of the solution. Neither unit identified was used in a transplant procedure, and the potential for a defect is considered very low.
The distributors are contacting all U.S. customers and asking them to return units from the specified lots for additional inspection by the manufacturer. UNOS is aware of this issue, so you do not need to report to UNOS if the distributor has contacted you. Please report to UNOS only if you are found to have contaminated solution and/or have observed adverse effects in patients that you strongly suspect are associated with contaminated solution.
Please refer to the linked documents for additional information regarding the lots affected and the process for returning the product.