Customed Breast Packs Recalled Due to Sterility Compromise and Contamination Risk
Customed, Inc. is recalling 36 breast packs 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 deficiencies '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 36 units of Breast Packs 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.
The recall is being issued because of serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions. These factors 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. The specific lot numbers involved are 140613789 and 140714519. Medical staff should stop using these products immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Breast Pack 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
- 36
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 140613789 140714519
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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