Medtronic Xomed, Inc. recalls Lamicel 20PK 3MM INTL Cervical dilator
Recalled Product
Lamicel 20PK 3MM INTL Cervical dilator
Hazard / Issue
Routine sterilization dose does not meet the required Sterility Assurance Level.
Issued by
FDA
Distribution: Affected product was only distributed in Japan.
Lot/Code Info: UDI: 20885074749024; SPONGE 2202-501EX LAMICEL 20PK 3MM INTL; 2202-501EX; Lots 9646605, 9651239, 9651240, 9651245, 9667694, 9667697, 9667756, 9669946, 9686127, 9686128, 9688076, 9693346, 9693347, 9693339, 9775264, 9799705, 9799708, 9811174, 9812616, 9819177, 9819513, 9819516, 9851438
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