Customed ENT Packs Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 140 ENT Packs due to compromised sterility and manufacturing deficiencies that may result in patient infection.
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 involves a risk-of-harm product (medical device) where the hazard is patient infection due to compromised sterility, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 140 units of the ENT Pack, Catalog number 900-1482. These medical devices are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are distributed in Florida, New York, and Puerto Rico.
The recall is being conducted because of compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. This may result in patient infection.
The affected lot numbers are 140513090, 140613609, 140714182, and 140814653. Medical facilities and consumers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- ENT Pack, Catalog number 900-1482. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 140
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 140513090 140613609 140714182 140814653
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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