Customed Universal Pack Recalled Due to Compromised Sterility
Customed, Inc. is recalling 45 Universal Packs (Catalog 900-1936) because compromised sterility and manufacturing deficiencies 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 recall involves a Class I medical device with a risk of patient infection due to compromised sterility, meeting the criteria for a Severe rating (FDA Class I or significant injury risk).
Plain-English summary
Customed, Inc. is recalling 45 units of the Universal Pack, Catalog number 900-1936. These medical packs are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are identified by lot numbers 140412891, 140613640, and 140714213.
The recall was initiated because the products have 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. This contamination may result in patient infection.
The products were distributed in the United States to Florida, New York, and Puerto Rico. Medical facilities and consumers who possess these specific lot numbers should stop using the products and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Universal Pack, Catalog number 900-1936. 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
- Hazard
- Affected units
- 45
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 140412891 140613640 140714213
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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