Customed Arthroscopy Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 180 Arthroscopy Packs (Catalog 900-1042) because manufacturing and storage deficiencies compromised sterility, posing a risk of 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 medical device with compromised sterility that may result in patient infection. This aligns with the 'Severe' criterion for significant injury reports or high-risk medical device defects where infection is a direct consequence of the defect.
Plain-English summary
Customed, Inc. is recalling 180 units of Arthroscopy Packs, Catalog number 900-1042. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because the products have compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. This contamination 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 140412451, 140513061, 140613568, 140714151, and 140814623. Medical facilities should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Arthroscopy Pack, Catalog number 900-1042. 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
- 180
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 140412451 140513061 140613568 140714151 140814623
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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