Customed Surgeon Gowns Recalled Due to Compromised Sterility and Contamination Risk
Customed, Inc. is recalling specific lots of Surgeon Gown Poly Reinforced Lgc because compromised sterility and inadequate storage conditions may increase the risk of 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 recall is due to compromised sterility and inadequate storage conditions that may result in patient infection. Under the severity rubric, FDA Class I recalls are never scored below 4 (Severe), and the risk of infection from non-sterile medical devices constitutes a significant injury risk.
Plain-English summary
Customed, Inc. is recalling 86,912 units of Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. These gowns are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The recall is due to compromised sterility, which is not limited to potentially damaged packaging.
The recall was initiated because of serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions. These factors increase the risk of contamination, which 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 should stop using the affected gowns immediately. The specific lot numbers subject to this recall are: 111103265, 111113126, 112010183, 112020505, 112030804, 112041056, 112051993, 112072804, 112093631, 112104361, 112104533, 112124897, 113026196, 113036804, 113057491, 113067873, 113078333, 113088873, 113099438, 113109852, 131110265, 131210654, 140111126, 140211540, 140312173, 140312384, 140513370, 140714295, 140814813, 140814957, and 140915481.
The recalled product
- Product
- Surgeon Gown Poly Reinforced Lgc, Catalog number 900-522. 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 Gowns
- Hazard
- Affected units
- 86,912
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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