Customed Laparotomy Packs Recalled for Sterility and Contamination Risks
Customed, Inc. is recalling 288 Laparotomy Packs due to compromised sterility and manufacturing deficiencies that may cause patient infection.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source explicitly states that the deficiencies 'may result in patient infection,' which aligns with the rubric criterion for 'significant injury' reports or risks in a Class I recall context.
Plain-English summary
Customed, Inc. is recalling 288 units of Laparotomy Packs, Catalog # 900-848. These medical supplies are used by staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being issued because of 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 140513146, 140513482, 140714310, and 140814684. Healthcare facilities and consumers should stop using these products and contact the manufacturer or the FDA for further instructions.
The recalled product
- Product
- Laparotomy Pack, Catalog # 900-848 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Affected units
- 288
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 140513146 140513482 140714310 140814684
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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