[Recalled] Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. — Customed products are being recalled because of compromi
A safety authority has issued a recall or warning for this item. The confirmed facts from the source notice are laid out below.
Recall details
| Product | Reyito Urological Pack, Catalog number 900-1460. Used by medical staff to perform patient care procedures such as wound healing, suture removals, irrigate wounds, etc. |
|---|---|
| Brand / manufacturer | Customed, Inc |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0292-2015 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 08 October 2014 |
| EAN / barcode | 140513089 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
This Class I 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
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
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.