Customed Plastic Surgery Packs Recalled for Compromised Sterility
Customed, Inc. is recalling 40 Plastic Surgery Packs due to compromised sterility and manufacturing deficiencies that may result in 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 compromised sterility 'may result in patient infection.' Under the severity rubric, a risk of significant injury (infection) from a medical device defect corresponds to a score of 4 (Severe), as it is not a Class I recall with reported deaths but presents a clear risk of harm.
Plain-English summary
Customed, Inc. is recalling 40 units of Plastic Surgery Packs, Catalog number 900-1402. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot numbers are 140513083 and 140814646.
The recall was initiated because of compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. This contamination may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who have these specific products should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Plastic Surgery Pack, Catalog number 900-1402. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 40
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 140513083 140814646
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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