Customed Arthroscopy Pack Recalled Due to Sterility and Contamination Risks
Customed, Inc. is recalling 200 Arthroscopy Packs (catalog #900-2473) 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 the risk may result in patient infection, which aligns with the 'significant injury' criteria for a Severe rating.
Plain-English summary
Customed, Inc. is recalling 200 units of the Arthroscopy Pack, catalog #900-2473, lot number 140513400. These medical supplies are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
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 possess these specific products should stop using them immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Arthroscopy Pack, catalog #900-2473 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 200
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 140513400
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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