[Recalled] Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . — Recall initiated due to inadequate validation/qualifica
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | Gown, surgical 30/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. . |
|---|---|
| Brand / manufacturer | Customed, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-2595-2015 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 10 July 2015 |
| EAN / barcode | 150518997 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Check whether your unit is affected and follow the authority's guidance before further use.
Read the full official notice →
Related recalls from Customed, Inc
This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.