Customed Transverse Laparotomy Packs Recalled for Sterility Compromise
Customed, Inc. is recalling 204 Transverse Laparotomy 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 source text explicitly states that the compromised sterility 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios warranting a Severe classification.
Plain-English summary
Customed, Inc. is recalling 204 units of the Transverse Laparotomy Pack (8), catalog #900-2491. These medical devices 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 140513220 and 140714250.
The recall is being conducted because of significant compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination. These conditions 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 products should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Transverse Laparotomy Pack (8), catalog #900-2491 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
- 204
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 140513220 140714250
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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