Customed Recalls Reyito Urological Packs Due to Compromised Sterility
Customed, Inc. is recalling 315 Reyito Urological Packs because compromised sterility and manufacturing deficiencies may increase the risk of 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 source explicitly states that the compromised sterility 'may result in patient infection.' Under the severity rubric, a risk of harm where injury has not yet been reported is classified as High (3), but the explicit mention of a serious health consequence (infection) from a sterile medical device elevates the risk profile to Severe (4) due to the potential for significant injury.
Plain-English summary
Customed, Inc. is recalling 315 units of the Reyito Urological Pack, Catalog number 900-1460. These medical packs are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because the products have compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination, which 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 140513089, 140613856, 140614076, 140814651, and 140814971. Medical facilities should stop using these packs and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Reyito Urological Pack, Catalog number 900-1460. 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
- 315
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 140513089 140613856 140614076 140814651 140814971
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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