Customed Premium OB Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 335 Premium OB Packs because compromised sterility and inadequate storage conditions 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 recall is due to compromised sterility and inadequate storage conditions that 'may result in patient infection.' This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios that pose a serious health threat, warranting a Severe classification.
Plain-English summary
Customed, Inc. is recalling 335 units of the Premium OB Pack, catalog number 900-1297. These products are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units were distributed in the United States to Florida, New York, and Puerto Rico.
The recall is being conducted because the products have compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. This risk may result in patient infection.
The affected lot numbers are 140513080, 140513459, 140613814, 140714432, and 140814944. Medical facilities and consumers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Premium OB Pack, Catalog number 900-1297. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Surgical Packs
- Hazard
- Affected units
- 335
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 140513080 140513459 140613814 140714432 140814944
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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