First Step Draco Pad, Product Number EP-4D
This recall has been terminated (originally issued May 8, 2019).
- Company
- Madison Polymeric Engineering
- Recall Initiated
- May 8, 2019
- Terminated
- July 6, 2020
- Recall Number
- Z-1925-2019
- Quantity
- 10570
- Firm Location
- Branford, CT
- Official Source
- View on FDA website ↗
Reason for Recall
This product has been contaminated with Stenotrophomonas lactiubi.
Distribution
The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, WA.
Lot / Code Info
Lot Numbers EX20191221X EX20191226X EX20191227X EX20191228X
Root Cause
Under Investigation by firm
Action Taken
Urgent Medical Device Recall notification letters dated 5/8/19 were sent to customers.
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