Customed Premium Cesarean Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 150 Premium Cesarean 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 explicitly states that the compromised sterility 'may result in patient infection,' which constitutes a significant injury risk under the rubric for Severe recalls.
Plain-English summary
Customed, Inc. is recalling 150 units of the Premium Cesarean Pack, catalog number 900-1294. These medical packs are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination and 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 140412594, 140513078, 140513477, 140714172, 140814642, and 140814732.
The recalled product
- Product
- Premium Cesarean Pack, Catalog number 900-1294 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
- 150
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 140412594 140513078 140513477 140714172 140814642 140814732
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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