Bridge to Life Ltd. and Waters Medical Systems have issued a notification of field correction for specified lots of Belzer UW Cold Storage Solution and IGL Cold Storage Solution in 2-liter bags manufactured by Preservation Solutions Inc (PSI). The distributors are contacting all U.S. customers and asking them to return all 2-liter bags for additional inspection by PSI. PSI has identified two units of product in the affected lots to have a pinhole leak at the base of the injection port in the 2-liter bags. 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 patient risk is considered very low.
The Field Correction will entail trained PSI personnel performing a 100% inspection of all 2-liter bags in specific lots that have been distributed to rule out the presence of the defect. Any 2-liter bag found to exhibit the defect will be destroyed. If an inspection by qualified personnel does not identify a defect, the product may be used. Also, please note that 1-liter solution bags are not subject to field correction.
The OPTN is aware of this issue, so you do not need to report to the OPTN if the distributor has contacted you. Please report to the OPTN only if you are found to have contaminated solution (presence of particulate matter, precipitates, or cloudiness) 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 process for returning the product.