FDA Device

Lamicel 20PK 3MM INTL Cervical dilator

Hazard

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

What You Should Do

Remedy

Medtronic will send the Consignee Notification and Customer Confirmation Form (or equivalent record) to each listed consignee. Consignees will be asked to confirm receipt of FCA notification.

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Products

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

Units Affected

29320 units

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