Customed Neuro Pack Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 114 Neuro Packs (catalog #900-2256) 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 deficiencies 'may result in patient infection,' which constitutes a significant injury risk. Per the rubric, risk-of-harm products with significant injury reports or potential are classified as Severe (4).
Plain-English summary
Customed, Inc. is recalling 114 units of the Neuro Pack, catalog #900-2256. This medical device is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are distributed in Florida, New York, and Puerto Rico.
The recall is being issued because of significant compromised sterility, which is not limited to potentially damaged packaging. The source text cites serious deficiencies in manufacturing processes and uncontrolled and inadequate storage conditions. These factors increase the risk of contamination and may result in patient infection.
The affected lot numbers are 140513128, 140613720, 140714240, 140814775, and 140915247. Medical facilities and consumers should stop using these products and contact the recalling firm for further instructions.
The recalled product
- Product
- Neuro Pack, catalog #900-2256 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
- 114
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 140513128 140613720 140714240 140814775 140915247
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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