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Class 2 Device Recall Lamicel Cervical Dilator |
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Date Initiated by Firm |
November 13, 2019 |
Create Date |
December 23, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0734-2020 |
Recall Event ID |
84332 |
PMA Number |
P820075 |
Product Classification |
dilator, cervical, synthetic, osmotic, pregnancy termination - Product Code LOB
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Product |
Lamicel 20PK 5MM INTL |
Code Information |
UDI: 20885074749055; SPONGE 2203-501EX LAMICEL 20PK 5MM INTL; 2203-501EX; Lots 9642542, 9657414, 9657415, 9657416, 9677915, 9707331, 9707338, 9707334, 9712918 |
Recalling Firm/ Manufacturer |
Medtronic Xomed, Inc. 6743 Southpoint Dr N Jacksonville FL 32216-6218
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For Additional Information Contact |
Mike Tomberlin 904-281-2769
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Manufacturer Reason for Recall |
Routine sterilization dose does not meet the required Sterility Assurance Level.
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FDA Determined Cause 2 |
Process control |
Action |
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. |
Quantity in Commerce |
307 packs; 6140 units |
Distribution |
Affected product was only distributed in Japan. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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PMA Database |
PMAs with Product Code = LOB and Original Applicant = Medtronic Xomed, Inc.
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