Date Initiated by Firm | July 24, 2019 |
Create Date | September 03, 2019 |
Recall Status1 |
Terminated 3 on May 11, 2020 |
Recall Number | Z-2448-2019 |
Recall Event ID |
83535 |
510(K)Number | K132022 |
Product Classification |
Catheter, intravascular occluding, temporary - Product Code MJN
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Product | The LeMaitre Aortic Occlusion Catheter is a single lumen catheter with a latex balloon, it is offered in two balloon sizes: 28 mm or 45mm. The single lumen acts as the inflation lumen for the balloon and is indicated by the white stopcock. Other features include a balloon wall thickness designed to reduce the possibility of puncture by calcium deposits, and a stop-cock to maintain balloon inflation level throughout the procedure. |
Code Information |
Lot # OLC1051 |
Recalling Firm/ Manufacturer |
LeMaitre Vascular, Inc. 63 2nd Ave Burlington MA 01803-4413
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For Additional Information Contact | Laurie Churchill 781-425-1670 |
Manufacturer Reason for Recall | incorrect device size being listed on the impacted device packaging |
FDA Determined Cause 2 | Labeling mix-ups |
Action | 1. Quarantine any catalog # 2107-80 devices from lot OLC1051.
2. Complete the enclosed customer reply form and return it to LeMaitre Vascular GmbH by scanning it and emailing it to recalls-emea@lemaitre.com.
NOTE: The customer reply form must be returned even if you have no devices at your facility.
3. LeMaitre Vascular GmbH will contact you with information on how to return the product and they will send you replacement devices.
For further information about this recall, contact Tobias Malcharczik at tmalcharczik@lemaitre.com. |
Quantity in Commerce | 62 units |
Distribution | GERMANY
FRANCE
SLOVENIA
SPAIN
SWEDEN
UK |
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database | 510(K)s with Product Code = MJN
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