Customed Open Heart Tray Recalled Due to Compromised Sterility
Customed, Inc. is recalling 160 Open Heart Trays (Catalog 900-170) due to compromised sterility and manufacturing deficiencies that may increase the risk of 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 involves a medical device with compromised sterility that may result in patient infection, meeting the criteria for a Severe (Score 4) recall due to significant injury risk.
Plain-English summary
Customed, Inc. is recalling 160 units of the Open Heart Tray, Catalog number 900-170. These trays are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall is due to compromised sterility, which is not limited to potentially damaged packaging.
The recall was initiated because of serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions. These issues increase the risk of contamination, which may result in patient infection. The affected lot numbers are 140513106, 140513245, 140613821, 140714336, 140814672, and 140814948.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers should stop using these specific trays and contact the manufacturer or their supplier for further instructions.
The recalled product
- Product
- Open Heart Tray, Catalog number 900-170. 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
- 160
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 140513106 140513245 140613821 140714336 140814672 140814948
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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