Customed Suction Catheter Kits Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 8,300 suction catheter kits distributed 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 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 identifies this as an FDA Class II recall involving a failure in the sterilization process for sterile medical devices. Per the rubric, FDA Class II recalls involving significant risks (such as potential infection from non-sterile devices) are classified as Severe.
Plain-English summary
Customed, Inc. is recalling 8,300 units of Suction Catheter Kits (Code 900277) that were distributed only in Puerto Rico. These medical devices are used by medical staff to perform surgical procedures and patient care tasks, 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 include 141015853, 150117020, 150317730, 150418230, and 150518789, with expiration dates ranging from January 31, 2016, to April 30, 2016.
This is an FDA Class II recall. Medical facilities and consumers in Puerto Rico who possess these specific lots should stop using the products and contact the manufacturer or the FDA for further instructions on how to return or dispose of the items.
The recalled product
- Product
- SUCTION CATHETER KIT CUSTOMED 50/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
- 8,300
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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