Customed OB Packs Recalled Due to Sterility and Contamination Risks
Customed, Inc. is recalling 80 OB Packs due to compromised sterility and manufacturing deficiencies that may result in 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 have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 80 units of OB Packs, catalog #900-254, used by medical staff for patient care procedures such as wound healing, suture removals, and wound irrigation. The recall is due to significant compromised sterility, which is not limited to potentially damaged packaging.
The recall was initiated because of serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions. These issues 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 140714253 and 140814783. Medical facilities should stop using these products and contact the recalling firm for instructions.
The recalled product
- Product
- OB Pack, catalog #900-254 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 80
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 140714253 140814783
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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