Customed Basic Pack 1 (III) Recalled for Sterility Compromise
Customed, Inc. is recalling 400 units of Basic Pack 1 (III) due to compromised sterility and manufacturing deficiencies that may cause 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 a significant risk of harm.
Plain-English summary
Customed, Inc. is recalling 400 units of Basic Pack 1 (III), catalog #900-2471. 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 140513219 and 140714247.
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. This contamination 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 immediately and contact the manufacturer or their supplier for instructions on return or disposal.
The recalled product
- Product
- Basic Pack 1 (III), catalog #900-2471 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
- 400
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 140513219 140714247
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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