Customed Foley Catheter Kit Recalled for Compromised Sterility
Customed, Inc. is recalling 9,770 Foley Catheter Kits due to compromised sterility and manufacturing deficiencies that may result in 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 recall involves a medical device with compromised sterility that may result in patient infection, meeting the criteria for a Severe (Score 4) classification due to significant injury risk.
Plain-English summary
Customed, Inc. is recalling 9,770 units of the Foley Catheter Kit, Catalog number 900-1127. This product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation. The affected units are identified by lot numbers 140513066, 140513253, 140613811, 140714388, and 140915251.
The recall was initiated because of compromised sterility, which is not limited to potentially damaged packaging. The source text indicates that serious deficiencies in manufacturing processes and uncontrolled, inadequate storage conditions increase the risk of contamination. These conditions 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 product and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- Foley Catheter Kit, Catalog number 900-1127. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Category
- Medical Device — Catheters
- Hazard
- Affected units
- 9,770
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 140513066 140513253 140613811 140714388 140915251
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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