Generic Name: Catheter With Transducer For Intracranial Pressure Measurement — Trade Names: (1) Codman Microsensor Basic Kit — (2) Codman Cerelink Icp Sensor

Recall Summary Integra Japan is recalling specific lots of CODMAN MicroSensor and Codman CereLink ICP Sensor devices, which are catheters used to measure pressure inside the skull. The recall was initiated because some units may have slight discoloration on internal needle components, though the amount of discoloration is extremely small. No serious health problems have been reported in Japan to date, and the manufacturer states that any potential minor reactions could be managed by medical staff.

Recalling firm

Name of Manufacturer and Distributor: Integra Japan Co., Ltd. — Address of Manufacturer and Distributor: 1-7-1 Akasaka, Minato-ku, Tokyo — License Type: Class I Medical Device Manufacturer and...

Product

Lot: 販売名：CODMAN MicroSensor ベーシック・キット 製品番号：826631 対象ロット： 5190243 5190245 5190246 5190247 5190248 5194236 5195674 5195675 5195676 5271156 5271161 5304136 5441655 5473767 5473768 5473769 5473770 5558319 5702606 5702607 5702608 5702609 5758737 5777440 5778093 5778097 5778098 5780632 5787911 5958122 5958128 6056425 6220306 6475104 6475106 6483303 6561122 6561125 6562820 6562824 6722641 6722642 6722643 6722644 6722645 6722646 6760050 6760051 6760052 6760053 6760054 6760057 6760059 6760060 6760062 6760063 6760065 6760066 6760068 6760069 6762192 6762193 6772461 6773900 6773902 6773906 6773916...

Reason

Following an investigation by the overseas manufacturer, it has been determined that we cannot rule out the possibility of slight discoloration on the inner surface of the toffee needles—a component of the product—in certain lots. Therefore, we are conducting a voluntary recall of the product.

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/2e0c7613-1bec-454c-9dd9-9c19bea3278c