Medtronic Xomed, Inc.: Lamicel 20PK 3MM INTL Cervical dilator

Is my product affected?

Lamicel 20PK 3MM INTL Cervical dilator

• UPC 20885074749024

Check against the official notice below — it lists the full affected range.

What happened

Medtronic Xomed, Inc. is recalling 29,320 units of Lamicel 20PK 3MM INTL cervical dilators distributed only in Japan. The recalled product has a sterilization issue: the routine sterilization dose does not meet the required Sterility Assurance Level. The affected lots are identified by UDI 20885074749024 and lot numbers ranging from 9646605 to 9851438.

The recall record does not specify a remedy or recommended action for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Routine sterilization dose does not meet the required Sterility Assurance Level.

Details from the source

Reason for recall: Routine sterilization dose does not meet the required Sterility Assurance Level. Distribution: Affected product was only distributed in Japan. Quantity: 29320 units 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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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