Customed Laparotomy Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 892 Laparotomy Packs (Catalog 900-149) because compromised sterility and inadequate storage conditions 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 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The source explicitly states the agency classification is Class I, which mandates a score of 5 per the rubric. Additionally, the hazard involves compromised sterility leading to patient infection, a serious health risk.
Plain-English summary
Customed, Inc. is recalling 892 units of Laparotomy Packs, Catalog number 900-149. These medical devices are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lots are 140412830, 140513345, 140613815, and 140714436.
The recall was initiated because the products have compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. This risk may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. The U.S. Food and Drug Administration has classified this as a Class I recall. Medical facilities and consumers should stop using these products and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Laparotomy Pack, Catalog number 900-149. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 892
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 140412830 140513345 140613815 140714436
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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