Customed Laparotomy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 400 Laparotomy Pack III units due to compromised sterility and manufacturing deficiencies that may cause 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 deficiencies 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects classified as Severe.
Plain-English summary
Customed, Inc. is recalling 400 units of Laparotomy Pack III (4), catalog #900-2492. These sterile packs are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected lot numbers are 140513131, 140613726, 140714251, and 140814779.
The recall was initiated because of significant compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions have increased the risk of contamination. These conditions may result in patient infection.
The 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
- Laparotomy Pack III (4), catalog #900-2492 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
- 400
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 140513131 140613726 140714251 140814779
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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