Customed Cysto Tur Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 380 Cysto Tur Packs because compromised sterility and manufacturing deficiencies 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 severity score of at least 4 according to the rubric. The source text explicitly states that the compromised sterility may result in patient infection.
Plain-English summary
Customed, Inc. is recalling 380 units of the Cysto Tur Pack, catalog number 900-080. This medical device is used by medical 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 the manufacturing processes and uncontrolled and inadequate storage conditions 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 140412449, 140513057, 140613558, 140714144, 140814613, and 140815030. Users should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Cysto Tur Pack, Catalog number 900-080. 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
- 380
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 140412449 140513057 140613558 140714144 140814613 140815030
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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