Customed Arthoscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 120 Arthoscopy 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 source text explicitly states that the deficiencies 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury' reports or risks, warranting a Severe (4) classification.
Plain-English summary
Customed, Inc. is recalling 120 units of Arthoscopy Pack, Catalog # 900-982. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall involves specific lot numbers: 140714319, 140814829, and 140915189.
The recall was initiated because of significant compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions have increased the risk of contamination. These conditions may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who possess these specific lot numbers should stop using the products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Arthoscopy Pack, Catalog # 900-982 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
- 120
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 140714319 140814829 140915189
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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