Customed Orthopedic Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 300 Orthopedic Packs due to compromised sterility and manufacturing deficiencies that may lead to 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 involves a Class I medical device with a risk of patient infection due to compromised sterility and manufacturing deficiencies, meeting the criteria for a Severe rating.
Plain-English summary
Customed, Inc. is recalling 300 units of the Orthopedic Pack, catalog #900-2830. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot numbers are 140714267 and 140814792.
The recall is being conducted 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 and may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers should stop using these products immediately and contact the manufacturer for further instructions.
The recalled product
- Product
- Orthopedic Pack, catalog #900-2830 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
- 300
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 140714267 140814792
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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