Customed Urology PK 5/CS Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 30 units of UROLOGY PK 5/CS kits 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 the hazard is theoretical (inadequate sterilization validation) and no injuries or illnesses are reported in the source text.
Plain-English summary
Customed, Inc. is recalling 30 units of UROLOGY PK 5/CS kits. These kits are used by medical staff to perform surgical procedures and patient care procedures, including wound healing, suture removals, and wound irrigation.
The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as package integrity issues for products released for distribution as sterile. The affected lots are 141015744 (exp. 11/30/15) and 150116698 (exp. 2/28/16), with code 9001742.
The products were distributed only in Puerto Rico. The source text does not specify instructions for consumers or medical staff on how to handle the recalled items.
The recalled product
- Product
- UROLOGY PK 5/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
- Category
- Medical Device — Surgical Kits
- Affected units
- 30
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)
- Code:9001742 Lots: 141015744 exp. 11/30/15 150116698 exp. 2/28/16
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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