Generic Name: Anesthesia IV Set — Brand Name: Cadd Anesthesia IV Set
Anesthesia IV Set Recall Summary ICU Medical Japan is recalling specific lots of CADD Anesthesia IV Sets (product number 21-7600-24, lot numbers 6037784 and 6054015) distributed between January and April 2025 due to weak welded seams in the bags that may cause anesthesia solution to leak during use. The leaking solution could delay or interrupt treatment, result in underdosing of medication, or expose patients to infection or harmful substances. No injuries have been reported in Japan to date, and the manufacturer notes that healthcare providers are instructed to stop using the sets immediately if any leakage is detected.
- Recalling firm
- Name of Manufacturer and Distributor: ICU Medical Japan Co., Ltd. — Address of Manufacturer and Distributor: Aoyama Yasuda Building, 7-1-1 Akasaka, Minato-ku, Tokyo — Type of License: Class I...
- Product
- Lot: 製品番号 ：21-7600-24 ロット番号：6037784, 6054015 出荷数量 ：8318個 出荷時期 ：令和7年1月8日〜令和7年4月24日. Use: 本品は、携帯型精密輸液ポンプである販売名「デルテックポンプCADDシリーズ」及び販売名「CADD-Solis ポン プ」に接続して使用する専用の輸液セットであり、麻酔用薬液等を注入する目的で使用する。. Health hazards: バッグ溶着部からの薬液漏れにより、治療の遅延または中断、薬液の過少投与、感染症または有害物質への曝露 を引き起こす可能性があります。しかしながら本製品の電子添文に、薬液充填中や輸液中に薬液漏れ等が認めら れた場合は、直ちに使用を中止することを記載しており、異常が確認された場合においても医療従事者監視下、 または医療従事者の指導のもと適切な処置が行われることから、これにより重篤な健康被害につながるおそれは ないと判断しております。 なお、現在までに国内おいて本不具合に関連する可能性のある健康被害は報告されておりません。
- Reason
- We have received notification from our overseas manufacturer regarding specific lots of the anesthesia infusion sets we manufacture and sell. Due to a manufacturing defect, the welded seams around the periphery of the bags inside the plastic cassettes may be weak in some cases, potentially causing the solution to leak from these seams. In light of this, and after carefully considering the product’s quality, efficacy, and safety, as well as the potential impact on patients and compliance with applicable laws and regulations, we have decided to voluntarily recall the affected products.
- Classification
- Class II
- Category
- medical device recall
- Country
- Japan
- Agency
- PMDA-DEVICE
- Status
- Ongoing
Official recall notice from PMDA-DEVICE
Recall details on Nibble Recalls: https://trynibble.app/recalls/828c83ad-c600-4c07-b002-e92b7ca570ca