Customed Cesarean Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 654 Cesarean 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 recall is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the source text explicitly states that the condition 'may result in patient infection,' indicating a risk of serious injury.
Plain-English summary
Customed, Inc. is recalling 654 units of the Cesarean Pack, Catalog number 900-403. This medical device is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being issued because of significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified serious deficiencies in the 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 140513246, 140613833, 140714545, and 140814876. Healthcare facilities and consumers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Cesarean Pack, Catalog number 900-403. 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
- Affected units
- 654
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 140513246 140613833 140714545 140814876
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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