Customed Cesarean Pack Recalled Due to Sterility and Contamination Risks
Customed, Inc. is recalling 260 Cesarean Packs (Catalog 900-410) due to compromised sterility and manufacturing deficiencies that may lead to 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 deficiencies 'may result in patient infection,' which constitutes a risk of significant injury. Per the rubric, risk-of-harm products where injury has not yet been reported but the potential for significant harm exists aligns with a score of 4 (Severe), particularly given the compromised sterility of a surgical pack.
Plain-English summary
Customed, Inc. is recalling 260 units of the Cesarean Pack, Catalog number 900-410. These medical supplies are used by medical staff for patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are identified by lot numbers 140513349, 140714284, and 140814546.
The recall was initiated due to significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified serious deficiencies in the manufacturing processes and uncontrolled, inadequate storage conditions. These factors 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. Medical facilities and consumers who have these specific lot numbers should stop using the products and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Cesarean Pack, Catalog number 900-410. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 260
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 140513349 140714284 140814546
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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