Customed Foley Catheter Kit Recalled Due to Compromised Sterility
Customed, Inc. is recalling 1,500 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in patient infection.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the compromised sterility 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios warranting a Severe classification.
Plain-English summary
Customed, Inc. is recalling 1,500 units of the Foley Catheter Kit, Catalog number 900-1139, Lot number 140613812. These kits are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because of compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers should stop using the affected products and contact the recalling firm for further instructions.
The recalled product
- Product
- Foley Catheter Kit, Catalog number 900-1139 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 1,500
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 140613812
Distribution
Part of a larger recall action
This product is one of 179 recalled by Customed, Inc 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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