Customed Liposuction Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 20 Liposuction Packs due to compromised sterility and manufacturing deficiencies that may lead to 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 conditions '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 rating.
Plain-English summary
Customed, Inc. is recalling 20 units of the Liposuction Pack, catalog #900-2656, lot number 140814938. These products are used by medical staff for patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to significant 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, potentially resulting in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who have these specific products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Liposuction Pack, catalog #900-2656 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
- Affected units
- 20
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 140814938
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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