Customed Labor and Delivery Surgical Packs Recalled for Sterilization Issues
Customed, Inc. is recalling 15 units of Labor and Delivery Surgical Packs due to inadequate sterilization validation and package integrity concerns.
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 surgical pack) where the hazard is theoretical (inadequate sterilization) and no injuries or illnesses have been reported in the source text.
Plain-English summary
Customed, Inc. is recalling 15 units of Labor and Delivery Surgical Packs (Catalog Number 900168). These products 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 concerns regarding package integrity for products released for distribution as sterile. The affected lots are SL15244, SL15245, and SL15251, all with a date code of 30-JUN-16.
The products were distributed only in Puerto Rico. Medical facilities and consumers who have these specific products should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- Catalog Number: 900168 LABOR & DELIVERY SURGICAL PACK 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
- 15
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 100 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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