Z-0734-2020 Class II Ongoing
FDA device recall Z-0734-2020 was initiated by Medtronic Xomed, Inc. on November 13, 2019 and is designated Class II. Reason for recall: Routine sterilization dose does not meet the required Sterility Assurance Level. The recall status is ongoing. Affected quantity: 307 packs; 6140 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 1, 2020
- Initiation Date
- November 13, 2019
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 307 packs; 6140 units
Product Description
Lamicel 20PK 5MM INTL
Reason for Recall
Routine sterilization dose does not meet the required Sterility Assurance Level.
Distribution Pattern
Affected product was only distributed in Japan.
Code Information
UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918