|
Class 2 Device Recall Lamicel Cervical Dilator |
|
Date Initiated by Firm |
November 13, 2019 |
Create Date |
December 23, 2019 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0733-2020 |
Recall Event ID |
84332 |
PMA Number |
P820075 |
Product Classification |
dilator, cervical, synthetic, osmotic, pregnancy termination - Product Code LOB
|
Product |
Lamicel 20PK 3MM INTL Cervical dilator |
Code Information |
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 |
Recalling Firm/ Manufacturer |
Medtronic Xomed, Inc. 6743 Southpoint Dr N Jacksonville FL 32216-6218
|
For Additional Information Contact |
Mike Tomberlin 904-281-2769
|
Manufacturer Reason for Recall |
Routine sterilization dose does not meet the required Sterility Assurance Level.
|
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 |
29320 units |
Distribution |
Affected product was only distributed in Japan. |
Total Product Life Cycle |
TPLC Device Report
|
|
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.
|
PMA Database |
PMAs with Product Code = LOB and Original Applicant = Medtronic Xomed, Inc.
|
|
|
|