Customed Recalls Carpal Tunnel Surgical Packs Due to Sterility Compromise
Customed, Inc. is recalling 660 Carpal Tunnel Surgical Large Packs due to compromised sterility and manufacturing deficiencies that may result in 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 explicitly states that the compromised sterility may result in patient infection, representing a serious health risk.
Plain-English summary
Customed, Inc. is recalling 660 units of the Carpal Tunnel Surgical Large Pack, Catalog # 900-742A. These medical device packs 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 of significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified serious deficiencies in the manufacturing processes and uncontrolled and 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. The specific lot numbers involved are 140312026, 140412702, 140513380, 140513481, 140714306, 140814551, and 140814961. Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Carpal Tunnel Surgical Large Pack, Catalog # 900-742A 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
- 660
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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