Customed Recalls Shoulder Arthroscopy Packs Due to Sterility Compromise
Customed, Inc. is recalling 270 units of Shoulder Arthroscopy Packs because compromised sterility and manufacturing deficiencies 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 recall involves a Class I medical device with a risk of patient infection due to compromised sterility, meeting the criteria for a Severe rating (score 4) as it involves significant injury risk without reported fatalities.
Plain-English summary
Customed, Inc. is recalling 270 units of Shoulder Arthroscopy Packs, catalog #900-2193. These medical devices are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall was initiated due to 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, potentially resulting 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 140513127, 140613830, 140714540, and 140814769. Healthcare facilities and consumers should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Shoulder Arthroscopy Pack, catalog #900-2193 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
- 270
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 140513127 140613830 140714540 140814769
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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