Customed Cysto Tur Pack Recalled Due to Sterility Compromise
Customed, Inc. is recalling 75 units of Cysto Tur Pack (Catalog 900-430) due to compromised sterility and manufacturing deficiencies that may cause 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 source text explicitly states that the deficiencies 'may result in patient infection,' which constitutes a risk of serious injury. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects, warranting a score of 4.
Plain-English summary
Customed, Inc. is recalling 75 units of the Cysto Tur Pack, Catalog number 900-430. This medical device is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units were distributed to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140111229, 140613760, and 140714287.
The recall was initiated because of significant 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. These conditions may result in patient infection.
Healthcare facilities and consumers who have these specific units should stop using them immediately. The recalling firm, Customed, Inc., is responsible for the recall. Users should contact the manufacturer for further instructions on how to return or dispose of the affected products.
The recalled product
- Product
- Cysto Tur Pack, Catalog number 900-430 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 Kits
- Affected units
- 75
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 140111229 140613760 140714287
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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