Customed Shoulder Packs Recalled Due to Sterility and Contamination Risks
Customed, Inc. is recalling 126 shoulder packs used for wound care 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 deficiencies 'may result in patient infection,' which constitutes a significant injury risk. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios.
Plain-English summary
Customed, Inc. is recalling 126 units of the Shoulder Pack, catalog #900-2766. These medical devices 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 significant 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 to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140312143, 140412666, 140513139, 140613734, 140714262, and 140814788. Users should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Shoulder Pack, catalog #900-2766 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Wound Care
- Hazard
- Affected units
- 126
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 140312143 140412666 140513139 140613734 140714262 140814788
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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