Customed OB Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 224 OB Packs used for patient care procedures due to compromised sterility and inadequate storage conditions 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 agency classification is FDA Class I, which mandates a minimum score of 4. The hazard involves compromised sterility leading to potential patient infection, which aligns with the 'Severe' criteria for significant injury risk.
Plain-English summary
Customed, Inc. is recalling 224 units of the OB Pack, Catalog number 900-1030. These medical supplies are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot numbers are 140513060, 140714150, and 140814622.
The recall was initiated because of compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. This risk may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Consumers and medical facilities should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- OB Pack, Catalog number 900-1030. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 224
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 140513060 140714150 140814622
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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