Customed Suction Catheter Kits Recalled for Compromised Sterility
Customed, Inc. is recalling Suction 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 source explicitly states that the deficiencies 'may result in patient infection,' which constitutes a significant injury risk. This aligns with the rubric criterion for 'significant injury/property-damage reports' or high-risk medical device defects.
Plain-English summary
Customed, Inc. is recalling Suction Catheter Kits, Catalog number 900-277, because of compromised sterility. The recall is not limited to potentially damaged packaging but includes serious deficiencies in manufacturing processes and uncontrolled storage conditions.
These deficiencies increase the risk of contamination, which may result in patient infection. The product is used by medical staff to perform patient care procedures such as wound healing, suture removals, and wound irrigation.
The recall affects 134,160 units distributed to Florida, New York, and Puerto Rico. Specific lot numbers are listed in the agency's recall record. Medical facilities should stop using these kits and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Suction Catheter Kit, Catalog number 900-277. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Manufacturer
- Customed, Inc
- Hazard
- Affected units
- 134,160
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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