[Recalled] CHS Custom Convenience Kit-TOENAIL REMOVAL TRAY Product Number: (1) ZZ-0956; (2) ZZ-0685 — Convenience kits were sealed in immediate Tyvek pouches using incorrect specifi… | FDA 2018-08-13

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

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 Custom Healthcare Systems, Inc.

• CHS Custom Convenience Kit-FOERSTER SPONGE FORCEPS, SERR, ST (9.5 ) Product Number:-D36-14623 — Class II
• CHS Custom Convenience Kit-BONE MARROW TRAY Product Number:B9-4000 — Class II
• CHS Custom Convenience Kit-COTTON TIP APPLICATORS, 10'S (6") Product Number:R1112B — Class II
• CHS Custom Convenience Kit-SUTURE REMOVAL KIT #1 Product Number: -ZZ-0664 — Class II
• CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B — Class II
• CHS Custom Convenience Kit-WEBSTER NEEDLE HOLDER Product Number:01-375C — Class II

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.