Customed Laparoscopy Chole Pack Recalled for Sterility Compromise
Customed, Inc. is recalling 440 units of Laparoscopy Chole 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 recall is classified as FDA Class I, which mandates a minimum severity score of 4. Additionally, the source text explicitly states that the compromised sterility 'may result in patient infection,' indicating a risk of serious injury.
Plain-English summary
Customed, Inc. is recalling 440 units of the Laparoscopy Chole Pack, Catalog number 900-414. This medical device is 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 140513363, 140613756, 140613835, and 140714394.
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 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. Healthcare 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
- Laparoscopy Chole Pack, Catalog number 900-414. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 440
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 140513363 140613756 140613835 140714394
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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