Customed Neuro Spine Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 207 Neuro Spine Packs because compromised sterility and manufacturing deficiencies 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.' Per the rubric, a risk-of-harm product where injury has not yet been reported but the hazard is significant (infection) aligns with a score of 4 (Severe), as it involves a significant health risk beyond minor labeling or cosmetic issues.
Plain-English summary
Customed, Inc. is recalling 207 units of the Neuro Spine Pack (Catalog number 900-1300). These medical supplies are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because the products have 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, which may result in patient infection.
The affected products were distributed in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140513082, 140613588, 140614074, 140714502, and 140814970. Medical facilities should stop using these products and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Neuro Spine Pack, Catalog number 900-1300 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 207
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 140513082 140613588 140614074 140714502 140814970
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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