Madison Polymeric Engineering Recalls First Step Draco Pads Due to Contamination
Madison Polymeric Engineering is recalling First Step Draco Pads (EP-4D) because they have been contaminated with Stenotrophomonas lactiubi.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a high-risk pathogen (Stenotrophomonas lactiubi) without reported illness, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Madison Polymeric Engineering is recalling the First Step Draco Pad, Product Number EP-4D. The recall involves 10,570 units of the product.
The FDA has identified that the product has been contaminated with Stenotrophomonas lactiubi. The affected lots are identified by the following numbers: EX20191221X, EX20191226X, EX20191227X, and EX20191228X.
The products were distributed to the following US states: AZ, CA, FL, IA, IL, IN, MA, MD, MO, PA, TN, TX, and WA. Consumers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled description.
The recalled product
- Product
- First Step Draco Pad, Product Number EP-4D
- Manufacturer
- Madison Polymeric Engineering
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 10,570
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Numbers EX20191221X EX20191226X EX20191227X EX20191228X
Distribution
Part of a larger recall action
This product is one of 2 recalled by Madison Polymeric Engineering under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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