Customed Foley Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 280 Foley Catheter Kits II in Puerto Rico due to inadequate validation of sterilization processes and package integrity.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterile medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Customed, Inc. is recalling 280 units of the Foley Catheter Kit II 18 FR 20/CS. These medical devices are used by medical staff to perform surgical procedures and patient care procedures, such as wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of the sterilization processes and package integrity for products that were released for distribution as sterile. The affected lots are 150117003 (exp. 2/28/16), 150317668 (exp. 4/30/16), and 150317669 (exp. 5/31/16), all under code 9001139.
The products were distributed only in Puerto Rico. The source text does not specify any reported illnesses or injuries associated with this recall.
The recalled product
- Product
- FOLEY CATHETER KIT II 18 FR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
- Manufacturer
- Customed, Inc
- Affected units
- 280
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 170 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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