| |
Class 2 Device Recall Draco |
 |
| Date Initiated by Firm |
May 08, 2019 |
| Create Date |
July 02, 2019 |
| Recall Status1 |
Terminated 3 on July 06, 2020 |
| Recall Number |
Z-1924-2019 |
| Recall Event ID |
82971 |
| Product Classification |
Accessories, cleaning brushes, for endoscope - Product Code MNL
|
| Product |
Draco Enzymatic Deep-Cleaning Pad with Ready-to-Use Enzymatic Detergent, Product Number HY0305Z |
| Code Information |
Lot Numbers EX20191121P EX20191126P EX20191127P EX20191212X EX20191213X EX20200125X |
Recalling Firm/
Manufacturer |
Madison Polymeric Engineering
965 W Main St
Branford CT 06405-3453
|
| For Additional Information Contact |
Cathey Szeto
203-488-4554
|
Manufacturer Reason
for Recall |
This product has been contaminated with Stenotrophomonas lactiubi.
|
FDA Determined
Cause 2 |
Under Investigation by firm |
| Action |
Urgent Medical Device Recall notification letters dated 5/8/19 were sent to customers. |
| Quantity in Commerce |
2723 |
| Distribution |
The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA. |
| 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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