Customed Universal Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 156 Universal Packs (Catalog 900-1587) because compromised sterility and manufacturing deficiencies may increase the risk of 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 are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 156 units of the Universal Pack, Catalog number 900-1587. This product is 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 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 in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140312077, 140412454, 140613617, 140714189, 140814665, and 140915233.
The recalled product
- Product
- Universal Pack, Catalog number 900-1587. 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
- 156
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 140312077 140412454 140613617 140714189 140814665 140915233
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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