Customed Arthroscopy Packs Recalled Due to Sterility Compromise
Customed, Inc. is recalling 75 Arthroscopy Packs due to compromised sterility and manufacturing deficiencies that may increase the risk of patient infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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. The source text explicitly states that the deficiencies may result in patient infection, representing a serious health risk.
Plain-English summary
Customed, Inc. is recalling 75 units of Arthroscopy Packs, catalog #900-2609. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lots are 140412660, 140513133, 140513402, 140613957, 140714513, and 140915132.
The recall is being conducted because of 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 issues 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 that received these products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Arthroscopy Pack, catalog #900-2609 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
- 75
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 140412660 140513133 140513402 140613957 140714513 140915132
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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