Customed Minor Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 944 Minor Packs due to compromised sterility and manufacturing deficiencies that may cause 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 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 944 units of the Minor Pack, catalog #900-2511. These sterile medical packs are 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 the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination, which 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 140412658, 140513479, 140613831, 140714542, and 140814781. Medical facilities should stop using these products and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Minor Pack, catalog #900-2511 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 944
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 140412658 140513479 140613831 140714542 140814781
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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