Customed Ear Pack Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 105 Ear Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
What this means for you
Illness, injury, or structural failure has been reported. 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.' 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 'patient infection' as a direct consequence of the defect elevates this to Severe (4) due to the significant injury risk associated with medical device sterility failures.
Plain-English summary
Customed, Inc. is recalling 105 units of the Ear Pack, catalog #900-2234. This product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall involves specific lot numbers: 140412835, 140512993, 140613955, 140714236, and 140814770.
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.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who have these specific lot numbers should stop using the product and contact the recalling firm for instructions.
The recalled product
- Product
- Ear Pack, catalog #900-2234 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 105
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 140412835 140512993 140613955 140714236 140814770
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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