| Date Initiated by Firm | May 27, 2020 |
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| Create Date | July 04, 2020 |
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| Recall Status1 |
Terminated 3 on March 29, 2021 |
| Recall Number | Z-2487-2020 |
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| Recall Event ID |
85776 |
| 510(K)Number | K974642 |
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| Product Classification |
Bronchoscope (flexible or rigid) - Product Code EOQ
|
| Product | Prodimed Combicath catheters for mini bronchoalveolar lavage (BAL)-COMBICATH PE 60 cm x 2.7 mm
Product Code: 58216 27US |
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| Code Information |
All lots within expiry |
Recalling Firm/
Manufacturer |
Prodimed Plastimed Division
3 Rue Louis Armand
Le Plessis Bouchard France
|
Manufacturer Reason
for Recall | Lack of assurance of sterility |
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FDA Determined
Cause 2 | Process control |
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| Action | Prodimed notified the Distributor by phone and email on 5/27/20 stating reason for recall, health risk, and action to take: Actions to be taken:
1. Immediately examine your inventory and quarantine product subject to recall.
2. In addition, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the attached Sub-Recall communication. This recall should be carried out to the user level.
3. Send back the response form completed, dated and signed as soon as possible by email to: customer-service@prodimed.com, or by fax: +33 23746388.
4. Make a weekly report to keep Prodimed informed of the progress of the recall.
5. After agreement of our Export Customer Service, proceed to the destruction of the recalled products quarantined (including products returned by your customers) in front of judicial officer with statement of destruction.
If you have any questions, contact the customer service on the following email: customerservice@prodimed.com or by phone: +33 2 37 65 86 20 |
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| Quantity in Commerce | 7220 |
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| Distribution | Nationwide |
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| 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 = EOQ
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