Customed Pediatric Lap Pack Recalled for Compromised Sterility
Customed, Inc. is recalling 56 Pediatric Lap Packs due to compromised sterility and manufacturing deficiencies that may result in 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 is classified as FDA Class I, which mandates a minimum severity score of 4 per the rubric, due to the reasonable probability that use of the product will cause serious adverse health consequences such as patient infection.
Plain-English summary
Customed, Inc. is recalling 56 units of the Pediatric Lap Pack, Catalog number 900-1383. These medical devices are used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall is being conducted because of compromised sterility, which is not limited to potentially damaged packaging. The FDA notes that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions 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. The specific lot numbers involved are 140613591, 140714175, and 140814645. Medical facilities should stop using these products and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Pediatric Lap Pack, Catalog number 900-1383 Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 56
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 140613591 140714175 140814645
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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