Customed Laparoscopy Packs Recalled Due to Sterility Compromise
Customed, Inc. is recalling 126 Laparoscopy Packs (Catalog 900-486) 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 recall is classified as FDA Class I, which mandates a severity score of at least 4 per the rubric. Additionally, the source text explicitly states the risk may result in patient infection, indicating a significant health hazard.
Plain-English summary
Customed, Inc. is recalling 126 units of the Laparoscopy Pack, Catalog number 900-486. 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 140513249, 140613839, and 140814809.
The recall is being issued because of significant compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in manufacturing processes and uncontrolled, 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 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 900-486. 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
- 126
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 140513249 140613839 140814809
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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