Customed Urology Packs Recalled for Sterilization Validation Issues
Customed, Inc. is recalling 155 Urology Packs 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 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 have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 155 units of Urology Packs (Code 900868) that were distributed exclusively in Puerto Rico. The recall was initiated because of inadequate validation and qualification of sterilization processes, as well as concerns regarding package integrity for products released for distribution as sterile.
The affected lots include 141015739 (exp. 11/30/15), 150116824 (exp. 2/28/16), 150217437 (exp. 3/31/16), 150317873 (exp. 4/30/16), and 150518844 (exp. 5/31/16). These products are used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, and wound irrigation.
The source text does not specify specific actions for consumers or medical facilities beyond the recall notice itself. Medical facilities should verify their inventory against the listed lot numbers and expiration dates.
The recalled product
- Product
- UROLOGY PACK 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 Packs
- Affected units
- 155
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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