Customed Extremity Arm Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 92 Extremity Arm Packs 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 agency classification is FDA Class I, which mandates a minimum severity score of 4 per the rubric. Additionally, the source text explicitly states the risk may result in patient infection, indicating a significant health hazard.
Plain-English summary
Customed, Inc. is recalling 92 units of the Extremity Arm Pack, catalog #900-2438. This product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are identified by lot numbers 140512912 and 140613725.
The recall was initiated because of significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions. These issues 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. Medical facilities and users should stop using the affected units immediately and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Extremity Arm Pack, catalog #900-2438 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Wound Care
- Affected units
- 92
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 140512912 140613725
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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