Customed Cesarean Packs Recalled Due to Compromised Sterility
Customed, Inc. is recalling 126 Cesarean 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 compromised sterility 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury' reports or risks.
Plain-English summary
Customed, Inc. is recalling 126 units of the Cesarean Pack, Catalog number 900-1689. 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, which may result in patient infection.
The affected products were distributed to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140513104, 140513464, and 140613820. Consumers and medical facilities should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- Cesarean Pack, Catalog number 900-1689. 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
- 126
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 140513104 140513464 140613820
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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