Customed Laparotomy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 288 Laparotomy Packs 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 text explicitly states that the conditions 'may result in patient infection' and cites 'serious deficiencies' in manufacturing and storage. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk contamination scenarios that pose a serious health threat, warranting a Severe (4) classification.
Plain-English summary
Customed, Inc. is recalling 288 units of Laparotomy Packs, catalog #900-2829. These medical supplies are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall covers specific lot numbers: 140513140, 140613736, 140714266, and 140814791.
The recall was initiated because of significant compromised sterility, which is not limited to potentially damaged packaging. 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 possess 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, catalog #900-2829 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 288
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 140513140 140613736 140714266 140814791
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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