Customed General Minor Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 680 General Minor 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.' Under the severity rubric, a risk-of-harm product where injury has not yet been reported is classified as High (3). However, the agency classification is Class I, and the rubric states that if the agency's own classification is FDA Class I, the score must never go below 4. Therefore, the score is 4 (Severe).
Plain-English summary
Customed, Inc. is recalling 680 units of the General Minor Pack, Catalog # 900-787. These sterile packs are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot numbers are 140513251, 140613847, 140714399, and 140814962.
The recall was initiated due to significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified serious deficiencies in the manufacturing processes and uncontrolled, 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. Medical facilities and consumers who have these specific lot numbers should stop using the products and contact the recalling firm or the FDA for further instructions.
The recalled product
- Product
- General Minor Pack, Catalog # 900-787 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 680
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 140513251 140613847 140714399 140814962
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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