Customed Cesarean Pack Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 264 Cesarean 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 recall involves a medical device with compromised sterility and manufacturing deficiencies that may result in patient infection, meeting the criteria for a Severe (Score 4) classification due to significant injury risk.
Plain-English summary
Customed, Inc. is recalling 264 units of the Cesarean Pack, Catalog # 900-851. These sterile packs are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are identified by lot numbers 140513147, 140513483, 140613782, 140714311, and 140814685.
The recall was initiated because of significant compromised sterility, which is not limited to potentially damaged packaging. The FDA identified serious deficiencies in the manufacturing processes and uncontrolled and 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 recalling firm for instructions on return or disposal.
The recalled product
- Product
- Cesarean Pack, Catalog # 900-851 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
- Affected units
- 264
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 140513147 140513483 140613782 140714311 140814685
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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