Customed Urology Pack Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 40 Urology Packs (Catalog 900-1738) due to compromised sterility and inadequate storage conditions that may result in 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' criteria for significant injury reports or high-risk medical device defects, though the agency classification is Class I.
Plain-English summary
Customed, Inc. is recalling 40 units of the Urology Pack, Catalog number 900-1738. These medical devices are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are identified by lot numbers 140211651, 140312085, 140714201, and 140915241.
The recall was initiated because the products have 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. This contamination may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Consumers and medical facilities should stop using these specific lots and contact the manufacturer or their supplier for instructions on return or disposal.
The recalled product
- Product
- Urology Pack, Catalog number 900-1738. 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
- Hazard
- Affected units
- 40
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 140211651 140312085 140714201 140915241
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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