Customed Open Heart Tray Recalled for Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 71 Open Heart Trays due to compromised sterility and manufacturing deficiencies that 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 source text 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 aligns with the 'Severe' (4) criteria for significant injury reports or high-risk medical device failures.
Plain-English summary
Customed, Inc. is recalling 71 units of the Open Heart Tray, Catalog number 900-1196C. These trays are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are associated with lot numbers 140513169, 140613799, 140714322, and 140814871.
The recall is being conducted because of compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination. This contamination may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who have these specific trays should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Open Heart Tray, Catalog number 900-1196C 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 Trays
- Hazard
- Affected units
- 71
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 140513169 140613799 140714322 140814871
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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