Customed Cystoscopy Pack III Recalled for Sterility Compromise
Customed, Inc. is recalling 200 units of Cystoscopy Pack III due to compromised sterility and manufacturing deficiencies that may cause 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 is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the hazard involves compromised sterility leading to potential patient infection, which constitutes a significant injury risk.
Plain-English summary
Customed, Inc. is recalling 200 units of Cystoscopy Pack III, catalog #900-2482. 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 due to 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 lot number is 140714248. The product was distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities should stop using the affected units and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Cystoscopy Pack III, catalog #900-2482 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
- 200
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 140714248
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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