Customed Recalls Knee Arthroscopy Packs Due to Sterility Compromise
Customed, Inc. is recalling 144 Knee Arthroscopy Packs because significant sterility compromises and manufacturing deficiencies 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 involves a Class I medical device with a risk of patient infection due to compromised sterility, which aligns with the 'Severe' criteria for significant injury risk or structural defects in medical devices.
Plain-English summary
Customed, Inc. is recalling 144 units of the Knee Arthroscopy Pack, catalog #900-2123. The product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is due to significant compromised sterility, which is not limited to potentially damaged packaging. Serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination and may result in patient infection.
The affected units were distributed in the United States to Florida, New York, and Puerto Rico. The specific lot numbers involved are 140513124, 140613657, 140714232, and 140814767. Healthcare facilities should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Knee Arthroscopy Pack, catalog #900-2123 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
- 144
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 140513124 140613657 140714232 140814767
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.
See all 179 products in this recall →Related recalls
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