Customed Laparoscopy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 48 Laparoscopy Packs due to compromised sterility and manufacturing deficiencies that may lead to 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 deficiencies 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury' reports or risks associated with FDA Class I recalls.
Plain-English summary
Customed, Inc. is recalling 48 units of Laparoscopy Packs, catalog number 900-484. These medical supplies are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall involves lot numbers 140613763 and 140714289.
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 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 Pack, Catalog number 900-484 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
- 48
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 140613763 140714289
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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