Customed Urology Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 195 Urology Packs due to compromised sterility and manufacturing deficiencies that may lead to 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 involves a medical device with compromised sterility and manufacturing deficiencies that may result in patient infection, meeting the criteria for a Severe rating due to significant injury risk.
Plain-English summary
Customed, Inc. is recalling 195 units of the Urology Pack, Catalog # 900-868. These sterile 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 issues 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 140513484, 140613783, 140714312, and 140814686. Medical facilities should stop using these packs and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Urology Pack, Catalog # 900-868 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 195
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 140513484 140613783 140714312 140814686
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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