Customed Tummy Tuck Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 18 Tummy Tuck Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the condition 'may result in patient infection' and cites 'serious deficiencies' in manufacturing and storage. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios that pose a serious health threat, warranting a Severe rating.
Plain-English summary
Customed, Inc. is recalling 18 units of the Tummy Tuck Pack, Catalog #900-3026, Lot 140714520. This medical device is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of 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 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 who have this product should stop using it and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Tummy Tuck Pack, Catalog #900-3026 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
- 18
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 140714520
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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