Customed Laparoscopy Packs Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling 156 Laparoscopy Packs (Catalog 900-1176) due to compromised sterility and manufacturing deficiencies that may result in patient infection.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where the hazard is patient infection due to compromised sterility, but no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 156 units of Laparoscopy Packs, Catalog number 900-1176. These sterile packs are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of compromised sterility, which is not limited to potentially damaged packaging. The source text cites serious deficiencies in manufacturing processes and uncontrolled, 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. The specific lot numbers involved are 140513071, 140513476, 140714159, 140814602, and 140915119. Medical facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Laparoscopy Pack, Catalog number 900-1176. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 156
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 140513071 140513476 140714159 140814602 140915119
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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