Customed O.B. Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 176 O.B. 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 explicitly states that the recall is due to compromised sterility and that the conditions 'may result in patient infection.' This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination in a medical context, warranting a Severe rating.
Plain-English summary
Customed, Inc. is recalling 176 units of the O.B. Pack (Catalog number 900-012). These medical supplies are used by 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 conducted because of 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 lot numbers are 140513051, 140613549, 140714119, 140814605, and 140815024. Medical facilities should stop using these products and contact the recalling firm for instructions on how to return or dispose of the affected units.
The recalled product
- Product
- O.B. Pack, Catalog number 900-012. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 176
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 140513051 140613549 140714119 140814605 140815024
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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